CompletedPhase 3

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

United States185 participantsStarted 2020-11-18

Plain-language 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

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Males or females ≥ 12 years of age
✓. Otherwise healthy and well controlled subjects

Exclusion criteria

✕. Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
✕. Unwilling or unable to discontinue use of contact lenses at screening until study completion
✕. Unwilling or unable to suspend use of topical medication at screening until study completion
✕. Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
✕. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
✕. Recent or current evidence of ocular infection or inflammation in either eye
✕. History of diabetic retinopathy or diabetic macular edema
✕. Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated

What they're measuring

Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline

Timeframe: 90 minutes

Trial details

NCT IDNCT04620213

SponsorOcuphire Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-23

Results submitted2023-06-23

View on ClinicalTrials.gov More Mydriasis trials