NCT01959230

Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Participants With Ocular Redness

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.

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: 2013-11-07
• Primary completion: 2013-12-20
• Completion: 2013-12-20
• First posted: 2013-10-09
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

1 site across 1 country: United States