CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 380 enrolled
Drug / intervention
Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation +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.

Search/NCT05360784
NCT05360784Phase 3Completed

The Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Preservative-Free Formulation With Lumify® 0.025% in Adult Subjects With Ocular Redness

Bausch & Lomb Incorporated·interventional·Posted May 4, 2022·Updated Aug 26, 2024

In Brief

A Phase 3 clinical trial evaluating Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation and Lumify® (brimonidine tartrate ophthalmic solution 0.025%) for Ocular Redness. Completed, enrolled 380 participants across 6 sites.

Detailed Summary

This is a multi-center, double-masked, randomized, active-controlled, parallel-group, efficacy and safety study that will enroll 386 participants at up to six clinical sites. Participants with ocular redness will be randomized to receive either brimonidine tartrate ophthalmic solution 0.025%, preservative-free formulation, or Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will be treated with study drug for approximately 4 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Redness
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMay 4, 2022
Enrollment StartMay 13, 2022
Primary CompletionNov 23, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.2 years ago

Interventions

Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulationdrug

Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation. Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.

Lumify® (brimonidine tartrate ophthalmic solution 0.025%)drug

Lumify® (brimonidine tartrate ophthalmic solution 0.025%). Participants will instill 1 drop of the assigned investigational drug in each eye 4 times a day approximately 4 hours apart for up to 4 consecutive weeks.