A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Brief 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date: November 2021
Estimated Primary Completion Date: November 2023
Estimated Study Completion Date: November 2023
Arm:
- Placebo Comparator: Placebo treatment
- Experimental: PHP-201 treatment
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 110 |
| Estimated Study start date | 01 November 2021 |
| Estimated Study Completion Date | 01 November 2023 |