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Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

NCT ID: NCT04343287

Last Updated: 2021-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2020-06-23

Brief Summary

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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

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This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double Masking

Study Groups

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BRM421 Ophthalmic Solution

A topical solution of BRIM421 ophthalmic drops

Group Type ACTIVE_COMPARATOR

BRM421

Intervention Type DRUG

The active control with BRM421 solution

Placebo

A vehicle ophthalmic drops

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The vehicle solution

Interventions

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BRM421

The active control with BRM421 solution

Intervention Type DRUG

Placebo

The vehicle 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ORA, Inc.

INDUSTRY

Sponsor Role collaborator

BRIM Biotechnology Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

Blair Boehmer, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Cornea Associates, LLC.

David Wirta, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Research Foundation

Eugene B McLaurin, MD

Role: PRINCIPAL_INVESTIGATOR

Total Eye Care, PA

Locations

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Eye Research Foundation

Newport Beach, California, United States

Site Status

Midwest Cornea Associates, LLC

Indianapolis, Indiana, United States

Site Status

Andover Eye Associates

Andover, Massachusetts, United States

Site Status

Total Eye Care

Memphis, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BRM421-18-C001-PR

Identifier Type: -

Identifier Source: org_study_id