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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status

Not yet recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Placebo ophthalmic solution

PHP-201 ophthalmic solution

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Glaucoma, Primary Open-angle Glaucoma, ROCK inhibitor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo treatment

PHP-201 treatment

Arm Description

A matching placebo ophthalmic solution, TID

PHP-201 0.5% ophthalmic solution, TID

Outcomes

Primary Outcome Measures

Intraocular Pressure

Mean IOP change from baseline

Secondary Outcome Measures

Diurnal intraocular pressure

Mean of diurnal IOP change from baseline

Full Information

NCT ID

NCT04863365

First Posted

April 26, 2021

Last Updated

June 13, 2021

Sponsor

pH Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04863365

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

pH Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Primary Open-angle Glaucoma, ROCK inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo treatment

Arm Type

Placebo Comparator

Arm Description

A matching placebo ophthalmic solution, TID

Arm Title

PHP-201 treatment

Arm Type

Experimental

Arm Description

PHP-201 0.5% ophthalmic solution, TID

Intervention Type

Drug

Intervention Name(s)

Placebo ophthalmic solution

Other Intervention Name(s)

Matching placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PHP-201 ophthalmic solution

Other Intervention Name(s)

Sovesudil

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular Pressure

Description

Mean IOP change from baseline

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Diurnal intraocular pressure

Description

Mean of diurnal IOP change from baseline

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

Treatment-emergent adverse event

Description

Safety assessed by number of participants experienced treatment-emergent adverse events

Time Frame

up to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Younyoung Hwang

Phone

+82 31 779 5301

younyoung.hwang@ph-pharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Younyoung Hwang

Organizational Affiliation

pH Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University Hopsital

City

Seoul

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

KiHo Park, MD. PhD

First Name & Middle Initial & Last Name & Degree

KiHo Park, MD. PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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