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Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

NCT03960866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-09-13

Study results available
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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.

Conditions

Interventions

DRUG

Phentolamine Mesylate Ophthalmic Solution 1%

Topical Sterile Ophthalmic Solution

OTHER

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Topical Sterile Ophthalmic Solution

Sponsors & Collaborators

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2019-09-11
Completion
2019-09-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960866 on ClinicalTrials.gov