NCT05815758

Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution, Used Two Times Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.

Detailed description

The study will consist of 4-5 study visits to compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis). To characterize the plasma pharmacokinetics (PK) of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution following a single dose and 22-day twice daily (BID) topical ocular dosing in a subset of healthy adult subjects.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo)	Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo)
DRUG	Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution	Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution

Timeline

• Start date: 2023-04-20
• Primary completion: 2023-09-18
• Completion: 2023-09-18
• First posted: 2023-04-18
• Last updated: 2025-07-10
• Results posted: 2025-07-10

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study