Dry EyePhase 2NCT03418727
Dry Eye Disease Study With Brimonidine
A Phase 2 study testing Brimonidine, Brimonidine Mono Therapy and sodium carboxymethylcellulose in people with Dry Eye, run by Ocugen at 3 sites in United States.
Trial summary
To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Brimonidine, Brimonidine Mono Therapy and sodium carboxymethylcellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Sep 2017to 29 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- 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
- Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:
- Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes
- Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
Show all 10Show fewer
- Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye
- Women who satisfy one of the following:
- 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, OR
- Are post-menopausal or have undergone a sterilization procedure
Who cannot join
- Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
- Use of contact lenses
- 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, institutionalized individuals, or others who may be considered vulnerable populations
- Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
- Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
- 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
3 sites in 1 country.
United States3 sites
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Brenart Eye Clinic
Yorkville, Illinois, 60560
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)
To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).
Read the detailed description
Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
- Conditions
- Dry Eye
- Being tested
- Brimonidine, Brimonidine Mono Therapy, sodium carboxymethylcellulose, Corticosteroid Eye Drop
- 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.
BrimonidineDrug
Two products delivered in sequence twice daily.
Brimonidine Mono TherapyDrug
Brimonidine given twice daily along with placebo drops
sodium carboxymethylcelluloseDrug
Placebo given twice daily.
Corticosteroid Eye DropDrug
Eye drop to be administered after Brimonidine in treatment arm 1
| Study group | Role | What they receive |
|---|---|---|
| Study Drug Arm #1 | Experimental | Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks Receives: Drug: Brimonidine; Drug: Corticosteroid Eye Drop |
| Study Drug Arm #2 | Experimental | Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks Receives: Drug: Brimonidine Mono Therapy |
| Control Arm | Placebo comparator | Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks Receives: Drug: sodium carboxymethylcellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Measured: Days 1, 28, 56, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start6 Sep 2017
- Primary completion29 Mar 2018
- Study completion29 Mar 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocugen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418727
- Sponsor's protocol ID
- OCU-310-DED-2017
- Status last verified
- Jun 2022
- First submitted
- 10 Oct 2017
- Last updated
- 6 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT03418727
- Acronym / sponsor ID
- OCU-310-DED-2017
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- OcugenIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Posted 6 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).
Detailed description
Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Drug Arm #1 | Experimental | Drug: Brimonidine, Drug: Corticosteroid Eye DropCombination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks |
| Study Drug Arm #2 | Experimental | Drug: Brimonidine Mono TherapyMonotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks |
| Control Arm | Placebo comparator | Drug: sodium carboxymethylcellulosePlacebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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
- Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:
- Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
Key exclusion criteria (16 listed)
- Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
- Use of contact lenses
- 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 |
|---|---|---|
| BrimonidineTwo products delivered in sequence twice daily. | Drug | Study Drug Arm #1 |
| Brimonidine Mono TherapyBrimonidine given twice daily along with placebo drops | Drug | Study Drug Arm #2 |
| sodium carboxymethylcellulosePlacebo given twice daily. | Drug | Control Arm |
| Corticosteroid Eye DropEye drop to be administered after Brimonidine in treatment arm 1 | Drug | Study Drug Arm #1 |
Primary outcome
Tolerance of Test Substance Visual Analogue Scale (VAS) Score
Time frame: Days 1, 28, 56, and 84
Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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.
3 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 Brimonidine, Brimonidine Mono Therapy and sodium carboxymethylcellulose in people with Dry Eye, run by Ocugen at 3 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 6 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 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 6 Jul 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?
Tolerance of Test Substance Visual Analogue Scale (VAS) Score (time frame: Days 1, 28, 56, and 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2022.