Dry EyePhase 3NCT03785340

Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)

A Phase 3 study testing Brimonidine Tartrate in people with Dry Eye, run by Ocugen at 16 sites in United States.

Completed

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

Trial summary

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: Brimonidine Tartrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 252 participants
Where: 16 sitesUnited States
Study dates: 3 Dec 2018to 25 Feb 2019
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease for ≥6 months
Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes

Show all 10Show fewer

Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
Women who satisfy one of the following:
8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure

Who cannot join

Allergic to brimonidine or any similar products, or excipients of brimonidine
Use of contact lenses within 14 days prior to Screening visit or planned use during study
Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
Intraocular pressure <5 mmHg or >22 mmHg in either eye
Active ocular infection or history of ocular herpetic keratitis

Show all 16Show fewer

History of neurotrophic keratitis or ocular neuropathic pain
Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
Punctal occlusion within 3 months prior to Screening visit or during study
Corneal epithelial defect larger than 1 mm2 in either eye
Have active drug/alcohol dependence or abuse history
Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Apex Eye- Kenwood
Cincinnati, Ohio, 45236
Apex Eye-Montgomery
Cincinnati, Ohio, 45242
Abrams Eye Center
Cleveland, Ohio, 44115
Scott and Christie Eyecare Associates
Cranberry Township, Pennsylvania, 16066
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
Midtown Eye Physicans & Associates
Houston, Texas, 77004
Advanced Laser Vision & Surgical Institute
Houston, Texas, 77034
Revolution Research, Inc; Lake Travis Eye and Laser Center
Lakeway, Texas, 78734
Total Eye Care
Memphis, Tennessee, 38119
Heart of America Eye Care, P. A.
Mission, Kansas, 66204
Toyos Clinic
Nashville, Tennessee, 37215
Aesthetic Eye Care Institute/David Wirta, MD and Associates
Newport Beach, California, 92663
Rand Eye Institute
Pompano Beach, Florida, 33064
Martel Medical Eye Group
Rancho Cordova, California, 95670
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Ophthalmology Associates
St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)

Read the detailed description

Dry eye disease (DED) is a common ocular disorder involving the aberrant production and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort.

This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 25 centers. Upon meeting the eligibility criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or ophthalmic buffered saline (placebo).

Conditions: Dry Eye
Being tested: Brimonidine Tartrate, Placebos
Keywords: Dry Eye Disease
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.

Brimonidine TartrateDrug
Also called OCU-310
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
PlacebosDrug
Also called Ophthalmic buffered saline solution
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.

Study groups in NCT03785340
Study group	Role	What they receive
OCU-310	Experimental	Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks Receives: Drug: Brimonidine Tartrate
Placebos	Placebo comparator	Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks Receives: Drug: Placebos

What is being measured

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

Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Measured: Baseline, 4 weeks (Day 28)
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Measured: Baseline, 4 Weeks (Day 28)

Secondary outcomes (2)

Change From Baseline to 2 Weeks (Day 14) in SANDE Score
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Measured: Baseline, 2 weeks (Day 14)
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Measured: Baseline, 2 Weeks (Day 14)

Timeline

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

3 Dec 201825 Feb 2019

First posted24 Dec 2018
Study start3 Dec 2018
Primary completion25 Feb 2019
Study completion25 Feb 2019

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.
Other trials for Dry EyeStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03785340
Sponsor's protocol ID: OCU-310-301
Status last verified: Jun 2022
First submitted: 20 Dec 2018
Last updated: 18 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)
ClinicalTrials.gov ID: NCT03785340
Acronym / sponsor ID: OCU-310-301
Conditions: Dry Eye
Keywords: Dry Eye Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: OcugenIndustry (pharma, biotech, devices)
Study start: 3 Dec 2018 (actual)
Primary completion: 25 Feb 2019 (actual)
Study completion: 25 Feb 2019 (actual)
First posted: 24 Dec 2018 (actual)
Results: Posted 6 Jun 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OCU-310	Experimental	Drug: Brimonidine TartrateBrimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
Placebos	Placebo comparator	Drug: PlacebosOphthalmic buffered saline Eye Drops given 2 times a day for 4 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease for ≥6 months
Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):
Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit

Key exclusion criteria (16 listed)

Allergic to brimonidine or any similar products, or excipients of brimonidine
Use of contact lenses within 14 days prior to Screening visit or planned use during study
Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
Intraocular pressure <5 mmHg or >22 mmHg in either eye

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
Brimonidine TartrateAlso: OCU-310Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.	Drug	OCU-310
PlacebosAlso: Ophthalmic buffered saline solutionOphthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.	Drug	Placebos

Primary outcome

Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
Time frame: Baseline, 4 weeks (Day 28)
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
Time frame: Baseline, 4 Weeks (Day 28)
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.

2 secondary outcomes

Change From Baseline to 2 Weeks (Day 14) in SANDE Score
Time frame: Baseline, 2 weeks (Day 14)
Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
Time frame: Baseline, 2 Weeks (Day 14)

Results and safety

Results posted to the registry on 6 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OCU-310	126	123
Placebo	126	126

Primary outcome: Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score

Time frame: Baseline, 4 weeks (Day 28). Mean (Standard Deviation). Unit: Score on a scale

Measure	OCU-310 n = 124	Placebo n = 124
Baseline	73.0 (13.6)	72.7 (12.4)
4 weeks (Day 28)	56.6 (23.2)	57.2 (19.8)
Change from Baseline at 4 weeks (Day 28)	-16.4 (20.9)	-15.5 (19.9)

OCU-310 vs Placebo: Least squares mean difference: -0.844 (95% CI -5.823 to 4.134), p = 0.739, Mixed Model Repeated Measures Analysis

Population analysed: The Intention-to-treat (ITT) set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.

Primary outcome: Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores

Time frame: Baseline, 4 Weeks (Day 28). Mean (Standard Deviation). Unit: score on a scale

Measure	OCU-310 n = 124	Placebo n = 124
Baseline	4.2 (1.1)	4.1 (1.0)
4 Weeks (Day 28)	3.6 (1.6)	3.2 (1.3)
Change from Baseline at 4 Weeks (Day 28)	-0.6 (1.4)	-0.9 (1.1)

Population analysed: The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent completion, throughout the study, and at early termination (Up to 28 Days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OCU-310	0 of 126 (0%)	0 of 126 (0%)	0 of 126
Placebo	0 of 126 (0%)	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 18 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brimonidine Tartrate in people with Dry Eye, run by Ocugen at 16 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 10 inclusion and 16 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jun 2022). 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?

Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score (time frame: Baseline, 4 weeks (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 NCT03785340.

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 18 Jul 2022.