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COMPLETED
NCT06803654
PHASE3

A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness

Sponsor: Bausch & Lomb Incorporated

View on ClinicalTrials.gov

Summary

To demonstrate the efficacy of BTOS-HA as non inferior to Lumify for treating ocular redness in a population of adult subjects.

Official title: A Randomized, Multicenter, Double-Masked, Active-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

578

Start Date

2025-05-22

Completion Date

2025-06-29

Last Updated

2026-05-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

BTOS-HA

Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart

DRUG

Lumify®

Brimonidine tartrate ophthalmic solution 0.025%, administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart

Locations (11)

Site 102

Glendale, California, United States

Site 104

Newport Beach, California, United States

Site 111

Northbrook, Illinois, United States

Site 109

Pittsburg, Kansas, United States

Site 106

Louisville, Kentucky, United States

Site 103

Andover, Massachusetts, United States

Site 108

Garner, North Carolina, United States

Site 107

Shelby, North Carolina, United States

Site 112

Cranberry Township, Pennsylvania, United States

Site 101

Memphis, Tennessee, United States

Site 105

Smyrna, Tennessee, United States