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

NCT04863365 | Unknown Phase 3

• 1 other identifier: PHP-201-S301
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Primary Open-angle Glaucoma; ROCK inhibitor

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure

  Mean IOP change from baseline

  4 weeks

Secondary Outcomes (1)

• Diurnal intraocular pressure

  4 weeks

Other Outcomes (1)

• Treatment-emergent adverse event

  up to 6 weeks

Study Arms (2)

Placebo treatment

PLACEBO COMPARATOR

A matching placebo ophthalmic solution, TID

Drug: Placebo ophthalmic solution

PHP-201 treatment

EXPERIMENTAL

PHP-201 0.5% ophthalmic solution, TID

Drug: PHP-201 ophthalmic solution

Interventions

Placebo ophthalmic solution DRUG

A matching placebo ophthalmic solution, 3 drops daily, 28 days

Also known as: Matching placebo

Placebo treatment

PHP-201 ophthalmic solution DRUG

PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days

Also known as: Sovesudil

PHP-201 treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• pH Pharma: lead

Study Sites (1)

Seoul National University Hopsital

Seoul, South Korea

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

sovesudil

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Younyoung Hwang

  pH Pharma

  STUDY DIRECTOR

Central Study Contacts

Younyoung Hwang

CONTACT

+82 31 779 5301; younyoung.hwang@ph-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)