At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 333 enrolled
Drug / intervention
Phentolamine Opthalmic Solution 0.75% +3 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, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia
In Brief
A Phase 3 clinical trial evaluating Phentolamine Opthalmic Solution 0.75%, Placebo, and 2 other interventions for Presbyopia. Completed, enrolled 333 participants across 26 sites.
Detailed Summary
The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedDec 2022
Enrollment StartDec 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedDec 12, 2022
Enrollment StartDec 22, 2022
Primary CompletionOct 11, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.6 years ago
Interventions
Phentolamine Opthalmic Solution 0.75%drug
phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
Placeboother
Vehicle for Phentolamine Ophthalmic Solution
Low dose pilocarpinedrug
Pilocarpine hydrochloride ophthalmic solution 0.4%
Low dose pilocarpine vehicleother
Vehicle for low dose pilocarpine