NCT01959243

Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperemia

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate	Ophthalmic solution to be applied as directed.
DRUG	Vehicle	Ophthalmic solution to be applied as directed.
DRUG	Sodium Fluorescein	For use as needed during the study for evaluating corneal damage.
DRUG	Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP	For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Timeline

• Start date: 2014-02-22
• Primary completion: 2014-04-23
• Completion: 2014-06-23
• First posted: 2013-10-09
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

4 sites across 1 country: United States