Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Glaucoma, Primary Open-angle Glaucoma, ROCK inhibitor
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.
Interventions
DRUGPlacebo ophthalmic solution
A matching placebo ophthalmic solution, 3 drops daily, 28 days
DRUGPHP-201 ophthalmic solution
PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days
Sponsors
pH Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | 4 weeks | Mean IOP change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diurnal intraocular pressure | 4 weeks | Mean of diurnal IOP change from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse event | up to 6 weeks | Safety assessed by number of participants experienced treatment-emergent adverse events |
Countries
South Korea
Contacts
Primary ContactYounyoung Hwang
Outcome results
None listed