Conditions: Hyperemia
Keywords: Ocular redness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 507
Healthy volunteers: yes

Brief summary:
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

Detailed description:

Arms:
arm 1: Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. arm 2: Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.

Interventions: intervention 1: Brimonidine Tartrate intervention 2: Vehicle intervention 3: Sodium Fluorescein intervention 4: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Intervention descriptions: intervention 1: Ophthalmic solution to be applied as directed. intervention 2: Ophthalmic solution to be applied as directed. intervention 3: For use as needed during the study for evaluating corneal damage. intervention 4: For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Protocol document: