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Not Yet RecruitingNCT07078955

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

A Phase 2, Multicenter, Randomized, Open-Labeled, Artificial Tear-Controlled, 6-Week Clinical Study to Assess the Dose Regimen, Safety and Efficacy of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
99 (estimated)
Sponsor
BRIM Biotechnology Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGBRM421 Ophthalmic Solution, 0.03%A topical drop of 0.03% BRM421 ophthalmic solution.
DRUGArtificial TearA topical drop of Artificial Tear.
DRUGBRM421 Ophthalmic Solution, 0.06%A topical drop of 0.06% BRM421 ophthalmic solution.

Timeline

Start date
2025-12-01
Primary completion
2026-11-01
Completion
2027-03-01
First posted
2025-07-22
Last updated
2025-10-20

Locations

1 site across 1 country: Taiwan

Regulatory

Source: ClinicalTrials.gov record NCT07078955. Inclusion in this directory is not an endorsement.