NCT03785340

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Ocugen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate	Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
DRUG	Placebos	Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2018-12-24
• Last updated: 2022-07-18
• Results posted: 2022-06-06

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study