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Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
The objectives of this study are: * To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD) * To evaluate efficacy of Nyxol to improve visual performance * To evaluate the safety of Nyxol
Placebo-controlled, double-masked, multiple-dose, Phase 3 study in approximately 160 randomized subjects with DLD (approximately 136 that are evaluable for efficacy), evaluating safety and efficacy of Nyxol in subjects with DLD following administration of Nyxol once daily (QD) at or near bedtime (at 8PM to 10PM) in both eyes (OU) for 14 days. Following the successful completion of screening, each subject will be stratified by iris color (light/dark irides) and will then be randomized to treatment (masked) 1:1, Nyxol or placebo (vehicle). Treatment (Nyxol or placebo) will be administered in both eyes (OU) by the subjects at or near bedtime each day. At the first visit subjects will be screened for study eligibility. Treatment visits will occur 2 times: Day 8 (+1 day)/Visit 2 and Day 15 (+1 day)/Visit 3. mLCVA evaluations shall be performed on each of these days. A follow-up visit (Visit 4) phone call will occur 1 to 3 days after Visit 3. At select sites OPD Scan measurements will be made using wavefront abhermettry.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Clinical Site 6
Newport Beach, California, United States
Clinical Site 1
Petaluma, California, United States
Clinical Site 3
Jacksonville, Florida, United States
Clinical Site 18
Jacksonville, Florida, United States
Clinical Site 13
Pittsburg, Kansas, United States
Clinical Site 20
Edgewood, Kentucky, United States
Clinical Site 14
Louisville, Kentucky, United States
Clinical Site 10
Palisades Park, New Jersey, United States
Clinical Site 8
Pennington, New Jersey, United States
Clinical Site 4
Elizabeth City, North Carolina, United States
Start Date
December 30, 2020
Primary Completion Date
May 19, 2022
Completion Date
May 19, 2022
Last Updated
October 14, 2025
144
ACTUAL participants
Phentolamine Ophthalmic Solution 0.75%
DRUG
Phentolamine Ophthalmic Solution Vehicle (Placebo)
DRUG
Lead Sponsor
Ocuphire Pharma, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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