NCT06803654

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 578 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Ocular Redness

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-22
• Primary completion: 2025-06-29
• Completion: 2025-06-29
• First posted: 2025-01-31
• Last updated: 2025-07-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study