NCT03066219

Safety and Efficacy of BRM421 for Dry Eye Syndrome

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: BRIM Biotechnology Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Detailed description

This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	BRM421	A topical solution of BRIM421 ophthalmic drops
DRUG	Placebo	vehicle ophthalmic drops

Timeline

• Start date: 2017-02-07
• Primary completion: 2017-05-20
• Completion: 2017-06-28
• First posted: 2017-02-28
• Last updated: 2017-11-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study