CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 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/NCT03960866
NCT03960866Phase 2Completed
CompareCT.gov

Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

Ocuphire Pharma, Inc.·interventional·Posted May 23, 2019·Updated Sep 13, 2023

In Brief

A Phase 2 clinical trial evaluating Phentolamine Mesylate Ophthalmic Solution 1% and Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) for Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 39 participants across 5 sites.

Detailed Summary

The objectives of this study are: * To evaluate the efficacy of Phentolamine Mesylate to lower intra-ocular pressure (IOP) in the treatment of Open-Angle Glaucoma (OAG) and Ocular Hypertension (OHT). * To evaluate the ocular and systemic safety of Phentolamine Mesylate compared to its vehicle. * To evaluate additional efficacy of Phentolamine Mesylate to improve visual performance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Angle Glaucoma, Ocular Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 23, 2019
Enrollment StartMay 28, 2019
Primary CompletionSep 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.1 years ago

Interventions

Phentolamine Mesylate Ophthalmic Solution 1%drug

Topical Sterile Ophthalmic Solution

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)other

Topical Sterile Ophthalmic Solution