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A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease

NCT07078955 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-10-20

No results posted yet for this study

Summary

To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)

Conditions

  • Dry Eye Disease (DED)
  • Keratoconjunctivitis Sicca

Interventions

DRUG

BRM421 Ophthalmic Solution, 0.03%

A topical drop of 0.03% BRM421 ophthalmic solution.

DRUG

Artificial Tear

A topical drop of Artificial Tear.

DRUG

BRM421 Ophthalmic Solution, 0.06%

A topical drop of 0.06% BRM421 ophthalmic solution.

Sponsors & Collaborators

  • BRIM Biotechnology Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-11-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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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 NCT07078955 on ClinicalTrials.gov