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COMPLETED
NCT03960866
PHASE2

Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Sponsor: Opus Genetics, Inc

View on ClinicalTrials.gov

Summary

The objectives of this study are: * To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT). * To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle. * To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.

Official title: Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2019-05-28

Completion Date

2019-09-11

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1%

Topical Sterile Ophthalmic Solution

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Locations (5)

North Valley Eye Medical Group

Mission Hills, California, United States

Clayton Eye Clinical Research

Morrow, Georgia, United States

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

Rochester Ophthalmological Group

Rochester, New York, United States

Abrams Eye Center

Cleveland, Ohio, United States