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Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Sponsor: Opus Genetics, Inc
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
Conditions
Interventions
Phentolamine Mesylate Ophthalmic Solution 1%
Topical Sterile Ophthalmic Solution
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