Status:
UNKNOWN
A Study of Efficacy and Safety of PHP-201 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
pH Pharma
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Subject
- 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
- Subject
Exclusion
- 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%
- 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
- Conditions need to wear contact lenses during the study
- Known hypersensitivity to any component of the investigational product
- 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
- Pregnant or breast-feeding
- Who disagreed with the use of the methods of proper contraception during the study duration
- Administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer
- Unsuitable for participation in the study according to the judgment of the investigator
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04863365
Start Date
November 1 2021
End Date
November 1 2023
Last Update
June 18 2021
Active Locations (1)
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1
Seoul National University Hopsital
Seoul, South Korea