NCT03418727

Dry Eye Disease Study With Brimonidine

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Ocugen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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

Interventions

Type	Name	Description
DRUG	Brimonidine	Two products delivered in sequence twice daily.
DRUG	Brimonidine Mono Therapy	Brimonidine given twice daily along with placebo drops
DRUG	sodium carboxymethylcellulose	Placebo given twice daily.
DRUG	Corticosteroid Eye Drop	Eye drop to be administered after Brimonidine in treatment arm 1

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-03-29
• Completion: 2018-03-29
• First posted: 2018-02-01
• Last updated: 2022-07-06
• Results posted: 2022-07-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study