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COMPLETED
NCT01703559
PHASE2

The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

Sponsor: Ocuphire Pharma, Inc.

View on ClinicalTrials.gov

Summary

The objectives of this study are: * To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity * To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Official title: Double-Masked Parallel Evaluation of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2011-09-09

Completion Date

2012-04-30

Last Updated

2026-10-08

Healthy Volunteers

Yes

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1.0%

Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist

DRUG

Phentolamine Mesylate Ophthalmic Solution 0.5%

Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

Locations (1)

Celerion

Phoenix, Arizona, United States