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Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

Ocular Hypertension Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Placebo-controlled double-masked, multiple dose Phase 2 study in 40 patients with IOP ≥ 22 and ≤30 mmHg, evaluating ocular and systemic safety and efficacy following administration of Phentolamine mesylate 1.0% QD at 8PM to 10PM in both eyes for 14 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03960866
Study type Interventional
Source Ocuphire Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date May 28, 2019
Completion date September 11, 2019
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