Clinical trial NCT04863365: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Primary Open-angle Glaucoma
ROCK inhibitor
Lead sponsor: pH Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-28
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: Diurnal intraocular pressure
timeFrame: 4 weeks
Other outcomes:
measure: Treatment-emergent adverse event
timeFrame: up to 6 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hopsital
Study officials:
affiliation: pH Pharma
name: Younyoung Hwang
role: STUDY_DIRECTOR
References: