At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Phentolamine Ophthalmic Solution 0.75% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% and Phentolamine Ophthalmic Solution Vehicle (Placebo) for Dim Light Vision Disturbances. Completed, enrolled 144 participants across 17 sites.
Detailed Summary
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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDim Light Vision Disturbances
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionMay 2022
TodayJul 2026
First PostedNov 20, 2020
Enrollment StartDec 30, 2020
Primary CompletionMay 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.6 years ago
Interventions
Phentolamine Ophthalmic Solution 0.75%drug
0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle (Placebo)drug
Topical sterile ophthalmic solution