Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis

NCT04620213 ↗

Phase 3 Completed 185 enrolled Ocuphire Pharma, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of this study are: * To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine * To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd) * To evaluate the safety of Nyxol * To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis

Timeline

Start: 2020-11-18
Primary completion: 2020-12-23
Completion: 2021-03-15

Publications

Pepose JS, Foster S, Pearson C, Brigell M, Charizanis K. Reversal of Pharmacologic Mydriasis in Pediatric Subjects with Ryzumvi (0.75% Phentolamine Ophthalmic Solution): A Post-Hoc Pooled Analysis from Three Randomized, Placebo-Controlled Phase 3 Trials. Clin Ophthalmol. 2026 Feb 20;20:563499. doi: 10.2147/OPTH.S563499. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phentolamine	Small molecule	0.75 %	Topical

Indications

No indication recorded.