Trial | NCT03066219  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    brm421 ...

  • Study Participants

    157
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.
This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).
Study Started
Feb 07
2017
Primary Completion
May 20
2017
Study Completion
Jun 28
2017
Last Update
Nov 22
2017

Drug BRM421

A topical solution of BRIM421 ophthalmic drops

Drug Placebo

vehicle ophthalmic drops

BRM421 Ophthalmic Solution Active Comparator

The active control with BRM421 solution

Placebo Placebo Comparator

The vehicle solution

Criteria 

Inclusion Criteria:

Be at least 18 years of age;
Provide written informed consent;
Have a reported history of dry eye for at least 6 months prior to enrollment;
Have a history of use of eye drops

Exclusion Criteria:

Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have used any eye drops within 2 hours of Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception
No Results Posted