Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2024-03-30

Brief Summary

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The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Masking

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BRM421 Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

BRM421 Ophthalmic Solution

Intervention Type DRUG

A topical drop of BRM421 ophthalmic solution.

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

A topical drop of vehicle (minus active) ophthalmic solution.

Interventions

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BRM421 Ophthalmic Solution

A topical drop of BRM421 ophthalmic solution.

Intervention Type DRUG

Vehicle

A topical drop of vehicle (minus active) ophthalmic solution.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye prior to enrollment;
* Have a history of use or desire to use 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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No