Dry Eye DiseasePhase 2NCT03452397

Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

A Phase 2 study testing 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL), 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) and 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) in people with Dry Eye Disease, run by Oyster Point Pharma, Inc. at 3 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

The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Dry Eye Disease
What is being tested?: 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL), 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) and 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 3 sitesUnited States
Study dates: 27 Feb 2018to 27 Apr 2018
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Who cannot join

Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
Have a known hypersensitivity to any of the procedural agents or study drug components
Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Andover
Andover, Massachusetts, 01810
Louisville
Louisville, Kentucky, 40206
Nashville
Nashville, Tennessee, 37210

Other trials in United States

About this study

Official title: Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.

Read the detailed description

This was a Phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of OC 02 Nasal Spray in adult participants with dry eye disease. Approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of OC-02 or placebo at Visit 1 and Visit 2.

Conditions: Dry Eye Disease
Being tested: 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL), 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL), 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL), Placebo (vehicle) nasal spray
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.

0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)Drug
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)Drug
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)Drug
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Placebo (vehicle) nasal sprayDrug
Placebo (vehicle) nasal spray

Study groups in NCT03452397
Study group	Role	What they receive
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	Active comparator	0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) Receives: Drug: 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	Active comparator	1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) Receives: Drug: 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Active comparator	2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) Receives: Drug: 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Placebo (vehicle) nasal spray	Placebo comparator	Placebo (vehicle) nasal spray Receives: Drug: Placebo (vehicle) nasal spray

What is being measured

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

Schirmer's Test Score at Day 1
The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Measured: Day 1 (Pre to Post-Treatment Change)
Eye Dryness Score at Visit 2
Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.
Measured: Day 15 (Pre to Post-Treatment Change)

Timeline

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

27 Feb 201827 Apr 2018

First posted2 Mar 2018
Study start27 Feb 2018
Primary completion27 Apr 2018
Study completion27 Apr 2018

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: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03452397
Sponsor's protocol ID: OPP-001
Status last verified: May 2019
First submitted: 26 Feb 2018
Last updated: 14 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Torkildsen GL, Pattar GR, Jerkins G, Striffler K, Nau J. Efficacy and Safety of Single-dose OC-02 (Simpinicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The PEARL Phase II Randomized Trial. Clin Ther. 2022 Sep;44(9):1178-1186. doi: 10.1016/j.clinthera.2022.07.006. Epub 2022 Aug 11.
PubMed 35965109

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
ClinicalTrials.gov ID: NCT03452397
Acronym / sponsor ID: OPP-001
Conditions: Dry Eye Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Oyster Point Pharma, Inc.Industry (pharma, biotech, devices)
Study start: 27 Feb 2018 (actual)
Primary completion: 27 Apr 2018 (actual)
Study completion: 27 Apr 2018 (actual)
First posted: 2 Mar 2018 (actual)
Results: Posted 14 Dec 2021

Clinical summary

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

The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	Active comparator	Drug: 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	Active comparator	Drug: 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Active comparator	Drug: 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Placebo (vehicle) nasal spray	Placebo comparator	Drug: Placebo (vehicle) nasal sprayPlacebo (vehicle) nasal spray

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1

Key exclusion criteria (5 listed)

Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of Visit 1
Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
Have a known hypersensitivity to any of the procedural agents or study drug components
Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

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
0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	Drug	0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	Drug	1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)	Drug	2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Placebo (vehicle) nasal sprayPlacebo (vehicle) nasal spray	Drug	Placebo (vehicle) nasal spray

Primary outcome

Schirmer's Test Score at Day 1
Time frame: Day 1 (Pre to Post-Treatment Change)
The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Eye Dryness Score at Visit 2
Time frame: Day 15 (Pre to Post-Treatment Change)
Change in Eye Dryness score from baseline to Day 15. Eye dryness score on a Visual Analogue Scale (VAS) from 0 (no discomfort) to 100 (maximum discomfort) millimeters where a lower score is indicative of a better outcome.

Results and safety

Results posted to the registry on 14 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.2% Hemigalactarate (0.11% Free Base) 0.2% OC-02 Mid Dose (1.1 mg/mL)	41	40
1% Hemigalactarate (0.11% Free Base) 1% OC-02 Mid Dose (5.5 mg/mL)	41	41
2% Hemigalactarate (0.11% Free Base) 2% OC-02 High Dose (11.1 mg/mL)	41	39
Placebo (Vehicle) Nasal Spray	42	41

Primary outcome: Schirmer's Test Score at Day 1

Time frame: Day 1 (Pre to Post-Treatment Change). Least squares mean (95% Confidence Interval). Unit: mm

Measure	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n = 41	1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) n = 41	2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL) n = 41	Placebo (Vehicle) Nasal Spray n = 42
Value	9.0 (6.3 to 11.6)	17.5 (14.8 to 20.2)	19.6 (16.9 to 22.3)	3.0 (0.3 to 5.6)

Population analysed: Subjects in the ITT population

Primary outcome: Eye Dryness Score at Visit 2

Time frame: Day 15 (Pre to Post-Treatment Change). Least squares mean (95% Confidence Interval). Unit: mm

Measure	0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL) n = 37	1 % Hemigalactarate (0.11% Free Base) 1 % OC-02 Mid Dose (5.5 mg/mL) n = 41	2 % Hemigalactarate (0.11% Free Base) 2 % OC-02 High Dose (11.1 mg/mL) n = 38	Placebo (Vehicle) Nasal Spray n = 41
Value	-9.4 (-15.4 to -3.5)	-17.4 (-23.1 to -11.7)	-20.7 (-26.7 to -14.7)	-6.5 (-12.1 to -0.8)

Population analysed: Subjects in the ITT Population. Only Subjects who had both pre-treatment and post-treatment values were utilized in the change from pre-treatment statistics

Adverse events

Time frame: Adverse events were collected from the first dose of study drug administration until the final study visit at Visit 2, up to 15 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL)	1 of 41 (2.4%)	17 of 41 (41.5%)	0 of 41
1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)	0 of 41 (0%)	23 of 41 (56.1%)	0 of 41
2.0 % Hemigalactarate (0.11% Free Base) 2.0 % OC-02 High Dose (11.1 mg/mL)	0 of 41 (0%)	24 of 41 (58.5%)	0 of 41
Placebo (Vehicle) Nasal Spray	0 of 42 (0%)	4 of 42 (9.5%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35965109Torkildsen GL, Pattar GR, Jerkins G, Striffler K, Nau J. Efficacy and Safety of Single-dose OC-02 (Simpinicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The PEARL Phase II Randomized Trial. Clin Ther. 2022 Sep;44(9):1178-1186. doi: 10.1016/j.clinthera.2022.07.006. Epub 2022 Aug 11.
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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 5 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 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 14 Dec 2021). 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?

Schirmer's Test Score at Day 1 (time frame: Day 1 (Pre to Post-Treatment Change)). 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 NCT03452397, 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 14 Dec 2021.