NCT04024891

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis. At the first visit subjects will be screened for study eligibility. After screening, eligible subjects will be randomized 1:1 to one of the two treatment sequences: Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2). Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2). Randomization will be stratified by mydriatic agent (2.5% phenylephrine or 1% tropicamide). Approximately one half of the randomized subjects will receive 2.5% phenylephrine and one half will receive 1% tropicamide. Subjects will receive their mydriatic agent 1 hour before treatment. Each subject will receive the same mydriatic agent throughout the study. At each visit, pupil diameter (PD), accommodation, near and distance visual acuity (VA) and redness in each eye will be measured before (-1 hour/baseline) and 1 hour after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e., right before the study treatment is administered), and at 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours after treatment dosing. As needed, two hours post treatment, subjects may request the administration of Lumify® in the non-study eye.

Conditions

• Mydriasis
• Dilation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-13
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2019-07-18
• Last updated: 2023-08-29
• Results posted: 2022-08-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study