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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Placebo ophthalmic solution
* Drug: PHP-201 ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Subject Inclusion Criteria: The age of 19 years or older Diagnosis of open-angle glaucoma (POAG) or ocular hypertension (OH) Intraocular Pressure(IOP) ≤ 35mmHg at both eye and IOP ≥ 22mmHg at either eye Shaffer's grading > 2 Best-corrected visual acuity in both eye equivalent to 0.2logMar Able and willing to give signed informed consent Subject Exclusion Criteria: Central corneal thickness <500㎛ or >600㎛ Medical history of following Closed-angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, narrow-angle glaucoma Advanced glaucomatous loss; mean deviation (MD) < -12dB Moderate to severe inflammatory/infectious disease in either eye Advanced retinopathy Surgical or laser therapy for glaucoma treatment Have confirmed the following at the screening visit SBP ≥ 180mmHg or DBP ≥ 110mmHg HbA1c > 9.0% CrCl < 30mL/min AST or ALT ≥ 3 X ULN Unstable angina, myocardial infarction, transient ischemic attack, cerebral stroke, coronary artery bypass graft, or coronary angioplasty within 24 weeks History of malignant tumor with 5 years History of the causative disease that may cause secondary glaucoma, including a history of steroid administration for more than 4 weeks Conditions need to wear contact lenses during the study Known hypersensitivity to any component of the investigational product Who has administered topical/systemic drugs that may affect the study within a certain period prior to eligibility check or are expected to need administration during the study duration Prostaglandin analogues: 5 weeks β-blockers: 4 weeks ROCK inhibitors: 4 weeks α/β-adrenergic agonists: 2 weeks Muscarinic agonists: 1 week Carbonic anhydrase inhibitors: 1 week Systemic corticosteroids: 4 weeks Pregnant or breast-feeding Who disagreed with the use of the methods of proper contraception during the study duration Administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer Unsuitable for participation in the study according to the judgment of the investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo treatment<br>A matching placebo ophthalmic solution, TID | Drug: Placebo ophthalmic solution<br>* A matching placebo ophthalmic solution, 3 drops daily, 28 days<br>* Other names: Matching placebo;|
| Experimental: PHP-201 treatment<br>PHP-201 0.5% ophthalmic solution, TID | Drug: PHP-201 ophthalmic solution<br>* PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days<br>* Other names: Sovesudil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Mean IOP change from baseline | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal intraocular pressure | Mean of diurnal IOP change from baseline | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Primary Open-angle Glaucoma, ROCK inhibitor