NCT03960866

Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Phentolamine Mesylate Ophthalmic Solution 1%	Topical Sterile Ophthalmic Solution
OTHER	Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)	Topical Sterile Ophthalmic Solution

Timeline

• Start date: 2019-05-28
• Primary completion: 2019-09-11
• Completion: 2019-09-11
• First posted: 2019-05-23
• Last updated: 2023-09-13
• Results posted: 2023-07-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study