Dry Eye DiseasePhase 2COMET-1NCT04498182

A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease

A Phase 2 study testing AR-15512 Ophthalmic Solution in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Dry Eye Disease
What is being tested?: AR-15512 Ophthalmic Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 369 participants
Where: 15 sitesUnited States
Study dates: 26 Oct 2020to 17 Jul 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Previous history of dry eye disease (DED) within the previous 6 months;
Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
Signs and symptoms of DED at the Screening and Baseline visits;
Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits;
Other protocol-specified inclusion criteria may apply.

Who cannot join

History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
Current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Andover Eye Associates
Andover, Massachusetts, 01810
Midwest Cornea Associates, LLC
Carmel, Indiana, 46290
Alpine Research Organization, Inc,
Clinton, Utah, 84015
Vision Institute
Colorado Springs, Colorado, 80907
Complete Eye Care of Medina
Hamel, Minnesota, 55340
Michael Washburn Center for Ophthalmic Research, LLC
Indianapolis, Indiana, 46240
Moyes Eye Center
Kansas City, Missouri, 64154
The Eye Care Institute
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care, PA
Memphis, Tennessee, 38119
Eye Research Foundation
Newport Beach, California, 92663
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, 85032
Andover Eye Associates
Raynham, Massachusetts, 02767
Vita Eye Clinic
Shelby, North Carolina, 28150
Advancing Vision Research, LLC
Smyrna, Tennessee, 37167

Other trials in United States

About this study

Official title: A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

Read the detailed description

At the end of the Screening Visit, all qualified subjects will be assigned to administer AR-15512 vehicle twice a day to both eyes for 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to receive AR-15512 0.0014% (lower dose), AR-15512 0.003% (higher dose) or AR-15512 vehicle administered as 1 drop in each eye twice daily for 84 days.

This study will utilize a Controlled Adverse Environment (CAE) chamber, which serves to (1) minimize the factors that could impact the evaluation (temperature, humidity, and airflow) and (2) stress the ocular surface in a safe, standardized, controlled, and reproducible manner. Subjects will be exposed to the CAE for approximately 90 minutes during each CAE visit. Subjects will be exposed to the CAE at the Screening and Baseline visits as well as on Day 28 (Visit 4) and Day 84 (Visit 5). Efficacy endpoints will be evaluated pre- and post- exposure to the CAE.

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Conditions: Dry Eye Disease
Being tested: AR-15512 Ophthalmic Solution, AR-15512 Ophthalmic Solution Vehicle
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AR-15512 Ophthalmic SolutionDrug
Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)
AR-15512 Ophthalmic Solution VehicleDrug
Ophthalmic solution vehicle administered via topical ocular instillation

Study groups in NCT04498182
Study group	Role	What they receive
AR-15512 Ophthalmic Solution Higher Dose	Experimental	AR-15512 Ophthalmic Solution 0.003%, one drop in each eye twice daily for 84 days. Both eyes will be treated. Receives: Drug: AR-15512 Ophthalmic Solution
AR-15512 Ophthalmic Solution Lower Dose	Experimental	AR-15512 Ophthalmic Solution 0.0014%, one drop in each eye twice daily for 84 days. Both eyes will be treated. Receives: Drug: AR-15512 Ophthalmic Solution
Vehicle	Placebo comparator	AR-15512 Ophthalmic Solution Vehicle, one drop in each eye twice daily for 84 days. Both eyes will be treated. Receives: Drug: AR-15512 Ophthalmic Solution Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 millimeters (mm) (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. This is a co-primary endpoint.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 28
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more positive change value indicates a better outcome. One eye (study eye) contributed data to the analysis. This is a co-primary endpoint.
Measured: Baseline (Day 1) (pre-treatment), Day 28

Secondary outcomes (36)

Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 84
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more positive change value indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 84
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). A higher score indicates a better outcome. The test was performed prior to CAE exposure. One eye (study eye) contributed data to the analysis.
Measured: Day 84
Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 28
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). A higher score indicates a better outcome. The test was performed prior to CAE exposure. One eye (study eye) contributed data to the analysis.
Measured: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 84
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 84
Ocular pain was assessed prior to CAE exposure using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 28
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 28
Ocular pain was assessed prior to CAE exposure using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 28
Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 84
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 84 following CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 84
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) following CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 84
Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 28
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 28 following CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 28
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) following CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 28
The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 28
The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 84
The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 84
The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28
Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness). Eye dryness was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28
Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84
Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness). Eye dryness was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84
Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 14
Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 28
Ocular discomfort was assessed using a 5-point proprietary scale where 0=no discomfort and 4=constant discomfort. Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 84
Ocular discomfort was assessed using a 5-point proprietary scale where 0=no discomfort and 4=constant discomfort. Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. The Day 84 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular discomfort) to 100 mm (maximum ocular discomfort) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 14
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 14
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain). Ocular pain was assessed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 14
Ocular pain was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no ocular pain) to 100 mm (maximum ocular pain) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 14
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 14
The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 14
The SANDE questionnaire assesses the frequency and severity of dry eye disease symptoms. Subjects used 2 unique, 100 mm Visual Analogue Scales (VAS) to mark the frequency of symptoms (0=rarely, 100=all the time) and the severity of symptoms (0=very mild, 100=very severe) for both eyes together. The Global SANDE score was calculated by multiplying the frequency score by the severity score and obtaining the square root. The final value was rounded nearest whole number. The SANDE questionnaire was completed prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 14
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14
Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness). Eye dryness was assessed at Baseline prior to CAE exposure and at Day 14 prior to CAE exposure. The Day 14 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14
Eye dryness was assessed using a Visual Analogue Scale (VAS) that ranged from 0 mm (no eye dryness) to 100 mm (maximum eye dryness) prior to CAE exposure. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Day 14
Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 84
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 84
Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 28
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 28
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 28
Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 84
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were the placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 84 prior to CAE exposure. A higher percentage indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) (pre-treatment), Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 202017 Jul 2021

First posted4 Aug 2020
Study start26 Oct 2020
Primary completion17 Jul 2021
Study completion17 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 369 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04498182
Sponsor's protocol ID: AR-15512-CS201
Acronym: COMET-1
Status last verified: Aug 2024
First submitted: 31 Jul 2020
Last updated: 28 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.
PubMed 42470519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)
ClinicalTrials.gov ID: NCT04498182
Acronym / sponsor ID: COMET-1 / AR-15512-CS201
Conditions: Dry Eye Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 369 participants (actual)
Lead sponsor: Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Oct 2020 (actual)
Primary completion: 17 Jul 2021 (actual)
Study completion: 17 Jul 2021 (actual)
First posted: 4 Aug 2020 (actual)
Results: Posted 6 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
AR-15512 Ophthalmic Solution Higher Dose	Experimental	Drug: AR-15512 Ophthalmic SolutionAR-15512 Ophthalmic Solution 0.003%, one drop in each eye twice daily for 84 days. Both eyes will be treated.
AR-15512 Ophthalmic Solution Lower Dose	Experimental	Drug: AR-15512 Ophthalmic SolutionAR-15512 Ophthalmic Solution 0.0014%, one drop in each eye twice daily for 84 days. Both eyes will be treated.
Vehicle	Placebo comparator	Drug: AR-15512 Ophthalmic Solution VehicleAR-15512 Ophthalmic Solution Vehicle, one drop in each eye twice daily for 84 days. Both eyes will be treated.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Previous history of dry eye disease (DED) within the previous 6 months;
Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
Signs and symptoms of DED at the Screening and Baseline visits;
Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
Current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AR-15512 Ophthalmic SolutionOphthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)	Drug	AR-15512 Ophthalmic Solution Higher Dose, AR-15512 Ophthalmic Solution Lower Dose
AR-15512 Ophthalmic Solution VehicleOphthalmic solution vehicle administered via topical ocular instillation	Drug	Vehicle

Primary outcome

Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 millimeters (mm) (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. This is a co-primary endpoint.
Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more positive change value indicates a better outcome. One eye (study eye) contributed data to the analysis. This is a co-primary endpoint.

36 secondary outcomes

Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28
Time frame: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84
Time frame: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 84
Time frame: Day 84
Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 28
Time frame: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 84
Time frame: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 28
Time frame: Day 28
Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 84
Time frame: Day 84
Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 28
Time frame: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 28
Time frame: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 84
Time frame: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28
Time frame: Day 28
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84
Time frame: Day 84
Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14
Time frame: Baseline (Day 1) (pre-treatment), Day 14
Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14
Time frame: Day 14
Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 14
Time frame: Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 14
Time frame: Day 14
Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 14
Time frame: Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 14
Time frame: Day 14
Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14
Time frame: Baseline (Day 1) (pre-treatment), Day 14
Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14
Time frame: Day 14
Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84
Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 28
Time frame: Baseline (Day 1) (pre-treatment), Day 28
Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 84
Time frame: Baseline (Day 1) (pre-treatment), Day 84

Results and safety

Results posted to the registry on 6 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AR-15512 Ophthalmic Solution Higher Dose	122	115
AR-15512 Ophthalmic Solution Lower Dose	121	114
Vehicle	126	116

Primary outcome: Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28

Time frame: Baseline (Day 1) (pre-treatment), Day 28. Least squares mean (Standard Error). Unit: millimeter (mm)

Measure	AR-15512 Ophthalmic Solution Higher Dose n = 118	AR-15512 Ophthalmic Solution Lower Dose n = 119	Vehicle n = 119
Value	-15.3 (2.14)	-11.0 (2.12)	-11.9 (2.15)

AR-15512 Ophthalmic Solution Higher Dose vs Vehicle: LS Mean Difference: -3.4 (95% CI -8.9 to 2.2), p = 0.2305, ANCOVA
AR-15512 Ophthalmic Solution Lower Dose vs Vehicle: LS Mean Difference: 0.9 (95% CI -4.6 to 6.4), p = 0.7436, ANCOVA

Population analysed: Intent-to-Treat (ITT) with data at both visits

Primary outcome: Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 28

Time frame: Baseline (Day 1) (pre-treatment), Day 28. Least squares mean (Standard Error). Unit: mm

Measure	AR-15512 Ophthalmic Solution Higher Dose n = 117	AR-15512 Ophthalmic Solution Lower Dose n = 116	Vehicle n = 118
Value	2.2 (0.53)	3.0 (0.53)	2.7 (0.53)

AR-15512 Ophthalmic Solution Higher Dose vs Vehicle: LS Mean Difference: -0.5 (95% CI -1.9 to 0.9), p = 0.4936, ANCOVA
AR-15512 Ophthalmic Solution Lower Dose vs Vehicle: LS Mean Difference: 0.3 (95% CI -1.1 to 1.6), p = 0.7131, ANCOVA

Population analysed: ITT with data at both visits

36 secondary outcomes are reported in the full results.

Adverse events

Time frame: An adverse event was (AE) defined as any untoward medical occurrence associated with the administration of the drug in humans, whether or not considered drug related. AE's were collected from time of consent until study exit, approximately 14 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 369 (0%)	11 of 369 (3%)	0 of 369
AR-15512 Ophthalmic Solution Higher Dose - Ocular	0 of 122 (0%)	53 of 122 (43.4%)	0 of 122
AR-15512 Ophthalmic Solution Higher Dose - Nonocular	1 of 122 (0.8%)	0 of 122 (0%)	0 of 122
AR-15512 Ophthalmic Solution Lower Dose - Ocular	0 of 121 (0%)	45 of 121 (37.2%)	0 of 121
AR-15512 Ophthalmic Solution Lower Dose - Nonocular	1 of 121 (0.8%)	0 of 121 (0%)	0 of 121
Vehicle - Ocular	0 of 126 (0%)	4 of 126 (3.2%)	0 of 126
Vehicle - Nonocular	2 of 126 (1.6%)	0 of 126 (0%)	0 of 126

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42470519Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scientific Advisor, Clinical Research and Development study director

Alcon Research, LLC

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AR-15512 Ophthalmic Solution in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28 (time frame: Baseline (Day 1) (pre-treatment), Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.