Dry Eye Disease Study With Brimonidine

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye

In brief

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).

Key facts

Study ID

NCT03418727

Run by

Ocugen

People needed

84

Starts

2017-09-06

Expected to finish

2018-03-29

Last updated by the study team

2022-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chicago Cornea Consultants — Hoffman Estates, Illinois, United States
• Brenart Eye Clinic — Yorkville, Illinois, United States
• The Eye Institute of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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