At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
BRM421 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model
In Brief
A Phase 3 clinical trial evaluating BRM421 and Placebo for Dry Eye Syndrome. Completed, enrolled 220 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedApr 2020
Primary CompletionJun 2020
TodayJul 2026
First PostedApr 13, 2020
Enrollment StartJan 15, 2020
Primary CompletionJun 23, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.2 years ago
Interventions
BRM421drug
The active control with BRM421 solution
Placebodrug
The vehicle solution