MedTrace Logo

Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

NCT04343287 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-05-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

BRM421

The active control with BRM421 solution

DRUG

Placebo

The vehicle solution

Sponsors & Collaborators

  • BRIM Biotechnology Inc.

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Andover Eye Associates

  • Blair Boehmer, MD · Midwest Cornea Associates, LLC.

  • David Wirta, MD · Eye Research Foundation

  • Eugene B McLaurin, MD · Total Eye Care, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2020-06-23
Completion
2020-06-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04343287 on ClinicalTrials.gov