- Males or females ≥ 12 years of age
- Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Healthy Subjects
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
March 18, 2022
Ocuphire Pharma, Inc.
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The safety and efficacy of the investigational use of these products have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.