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Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)
Sponsor: Opus Genetics, Inc
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
Phentolamine Ophthalmic Solution 0.75%
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
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