CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Phentolamine Mesylate Ophthalmic Solution 1% +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.

Search/NCT04024891
NCT04024891Phase 2Completed
CompareCT.gov

Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects

Ocuphire Pharma, Inc.·interventional·Posted Jul 18, 2019·Updated Aug 29, 2023

In Brief

A Phase 2 clinical trial evaluating Phentolamine Mesylate Ophthalmic Solution 1% and Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) for Mydriasis and Dilation. Completed, enrolled 32 participants across 4 sites.

Detailed Summary

The objectives of this study are: * To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis * To evaluate the safety of Nyxol * To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMydriasis, Dilation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 18, 2019
Enrollment StartAug 13, 2019
Primary CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.0 years ago

Interventions

Phentolamine Mesylate Ophthalmic Solution 1%drug

1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)other

Topical Sterile Ophthalmic Solution