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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Drug: Placebo ophthalmic solution; Drug: PHP-201 ophthalmic solution

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
• Enrollment (Anticipated): 110
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Younyoung Hwang; Phone Number: +82 31 779 5301; Email: younyoung.hwang@ph-pharma.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hopsital
    • Contact: KiHo Park, MD. PhD
    • Principal Investigator: KiHo Park, MD. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Subject Inclusion Criteria:

1. The age of 19 years or older
2. Diagnosis of open-angle glaucoma (POAG) or ocular hypertension (OH)
3. Intraocular Pressure(IOP) ≤ 35mmHg at both eye and IOP ≥ 22mmHg at either eye
4. Shaffer's grading > 2
5. Best-corrected visual acuity in both eye equivalent to 0.2logMar
6. Able and willing to give signed informed consent

Subject Exclusion Criteria:

1. Central corneal thickness <500㎛ or >600㎛

2. 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

3. 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
4. Conditions need to wear contact lenses during the study
5. Known hypersensitivity to any component of the investigational product

6. 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
7. Pregnant or breast-feeding
8. Who disagreed with the use of the methods of proper contraception during the study duration
9. Administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer
10. Unsuitable for participation in the study according to the judgment of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse event	Safety assessed by number of participants experienced treatment-emergent adverse events	up to 6 weeks

Collaborators and Investigators

• Sponsor: pH Pharma
• Investigators: Study Director: Younyoung Hwang, pH Pharma

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Glaucoma; Primary Open-angle Glaucoma; ROCK inhibitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: PHP-201-S301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No