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.

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.

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