Overview

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)

Status:
Not yet recruiting

Trial end date:
2022-07-01

Target enrollment:

Participant gender:

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 - To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling

Phase:

Phase 3

Details

Lead Sponsor:

Ocuphire Pharma, Inc.

Treatments:

Ophthalmic Solutions
Pharmaceutical Solutions
Phentolamine