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COMPLETED
NCT04024891
PHASE2

Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis

Sponsor: Opus Genetics, Inc

View on ClinicalTrials.gov

Summary

The objectives of this study are: * To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis * To evaluate the safety of Nyxol * To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol

Official title: Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2019-08-13

Completion Date

2019-09-17

Last Updated

2026-10-30

Healthy Volunteers

Yes

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1%

1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Locations (4)

Kannar Eye Care

Pittsburg, Kansas, United States

Kentucky Eye Institute

Lexington, Kentucky, United States

Athens Eye Care

Athens, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, United States