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