NCT04863365

A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

A Multi-center, Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PHP-201 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: pH Pharma · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description

As a selective ROCK inhibitor, PHP-201 is designed to alleviate the side effects, which are the disadvantages of existing intraocular pressure reducing agents, while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients. This clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of PHP-201 0.5% in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Placebo ophthalmic solution	A matching placebo ophthalmic solution, 3 drops daily, 28 days
DRUG	PHP-201 ophthalmic solution	PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-04-28
• Last updated: 2021-06-18

Locations

1 site across 1 country: South Korea