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COMPLETED
NCT04620213
PHASE3

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

Sponsor: Opus Genetics, Inc

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

185

Start Date

2020-11-18

Completion Date

2021-03-15

Last Updated

2026-10-30

Healthy Volunteers

Yes

Interventions

DRUG

Phentolamine Ophthalmic Solution 0.75%

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

OTHER

Phentolamine Ophthalmic Solution Vehicle (Placebo)

Topical sterile ophthalmic solution

Locations (12)

Clinical Site 11

Newport Beach, California, United States

Clinical Site 10

San Diego, California, United States

Clinical Site 9

Longwood, Florida, United States

Clinical Site 6

Orlando, Florida, United States

Clinical Site 2

Roswell, Georgia, United States

Clinical Site 7

Pittsburg, Kansas, United States

Clinical Site 3

Shawnee Mission, Kansas, United States

Clinical Site 5

Athens, Ohio, United States

Clinical Site 12

Cincinnati, Ohio, United States

Clinical Site 1

Cleveland, Ohio, United States

Clinical Site 8

Warwick, Rhode Island, United States

Clinical Site 4

Memphis, Tennessee, United States