NCT05360784

"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Redness

Interventions

Type	Name	Description
DRUG	Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation	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.
DRUG	Lumify® (brimonidine tartrate ophthalmic solution 0.025%)	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.

Timeline

• Start date: 2022-05-13
• Primary completion: 2022-11-23
• Completion: 2022-11-23
• First posted: 2022-05-04
• Last updated: 2024-08-26
• Results posted: 2024-08-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study