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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: pH Pharma
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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