NCT04004507

Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: * To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints: 1. Contrast sensitivity 2. Low contrast visual acuity 3. Wavefront aberrometry 4. Subjective questionnaire * To assess the safety of ophthalmic phentolamine mesylate

Detailed description

Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.

Conditions

• Decrease in Night Vision
• Disturbance; Vision, Loss

Interventions

Type	Name	Description
DRUG	Phentolamine Mesylate Ophthalmic Solution 1%	Topical Sterile Ophthalmic Solution
OTHER	Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)	Topical Sterile Ophthalmic Solution

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-10-01
• Completion: 2008-02-01
• First posted: 2019-07-02
• Last updated: 2024-02-15
• Results posted: 2024-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study