Status:
COMPLETED
Dry Eye Disease Study With Brimonidine
Lead Sponsor:
Ocugen
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
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 ...
Eligibility Criteria
Inclusion
- 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:
- i. 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03418727
Start Date
September 6 2017
End Date
March 29 2018
Last Update
July 6 2022
Active Locations (3)
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1
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States, 60169
2
Brenart Eye Clinic
Yorkville, Illinois, United States, 60560
3
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107