NCT05579730

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

Evaluation of Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Brimonidine tartrate 0.025%/ketotifen fumarate 0.035%	combination ophthalmic solution
DRUG	Brimonidine Tartrate 0.025%	ophthalmic Solution
DRUG	Ketotifen Fumarate 0.035%	ophthalmic Solution
DRUG	Vehicle	ophthalmic Solution

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-07-22
• Completion: 2023-07-22
• First posted: 2022-10-14
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study