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
Overview
- Phase
- Phase 3
- Intervention
- Placebo ophthalmic solution
- Conditions
- Primary Open Angle Glaucoma
- Sponsor
- pH Pharma
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Intraocular Pressure
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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%
Arms & Interventions
Placebo treatment
A matching placebo ophthalmic solution, TID
Intervention: Placebo ophthalmic solution
PHP-201 treatment
PHP-201 0.5% ophthalmic solution, TID
Intervention: PHP-201 ophthalmic solution
Outcomes
Primary Outcomes
Intraocular Pressure
Time Frame: 4 weeks
Mean IOP change from baseline
Secondary Outcomes
- Diurnal intraocular pressure(4 weeks)