NCT05591755

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis

Evaluation of the Combination Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution Compared to Its Components and Vehicle in an Allergen BioCube® in Subjects With Seasonal Allergic Conjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic conjunctivitis.

Conditions

• Seasonal Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution
DRUG	Ketotifen fumarate ophthalmic solution 0.035%	Ketotifen fumarate ophthalmic solution 0.035%
DRUG	Brimonidine tartrate ophthalmic solution 0.025%	Brimonidine tartrate ophthalmic solution 0.025%
DRUG	Experimental: Vehicle ophthalmic solution	Experimental: Vehicle ophthalmic solution

Timeline

• Start date: 2022-11-18
• Primary completion: 2023-08-09
• Completion: 2023-08-09
• First posted: 2022-10-24
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study