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COMPLETED
NCT05134974
PHASE3

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

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

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

368

Start Date

2021-11-18

Completion Date

2022-03-29

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

DRUG

Phentolamine Ophthalmic Solution Vehicle

Phentolamine Ophthalmic Solution Vehicle

Locations (15)

Clinical Site 10

Newport Beach, California, United States

Clinical Site 12

Westminster, California, United States

Clinical Site 9

Delray Beach, Florida, United States

Clinical Site 8

Longwood, Florida, United States

Clinical Site 6

Morrow, Georgia, United States

Clinical Site 1

Roswell, Georgia, United States

Clinical Site 13

Lake Villa, Illinois, United States

Clinical Site 5

Pittsburg, Kansas, United States

Clinical Site 2

Bloomington, Minnesota, United States

Clinical Site 15

Garner, North Carolina, United States

Clinical Site 4

Athens, Ohio, United States

Clinical Site 14

Shrewsbury, Pennsylvania, United States

Clinical Site 7

Warwick, Rhode Island, United States

Clinical Site 11

Sioux Falls, South Dakota, United States

Clinical Site 3

Memphis, Tennessee, United States