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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04863365
• Other study ID #: PHP-201-S301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 2021
• Est. completion date: November 2023

Study information

• Verified date: April 2021
• Source: pH Pharma
• Contact: Younyoung Hwang
• Phone: +82 31 779 5301
• Email: younyoung.hwang[@]ph-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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
• ß-blockers: 4 weeks
• ROCK inhibitors: 4 weeks
• a/ß-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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• Placebo ophthalmic solution
A matching placebo ophthalmic solution, 3 drops daily, 28 days
• PHP-201 ophthalmic solution
PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hopsital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
pH Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment-emergent adverse event	Safety assessed by number of participants experienced treatment-emergent adverse events	up to 6 weeks
Primary	Intraocular Pressure	Mean IOP change from baseline	4 weeks
Secondary	Diurnal intraocular pressure	Mean of diurnal IOP change from baseline	4 weeks