Normal Tension Glaucoma
Conditions
Brief summary
Evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with normal tension glaucoma
Detailed description
Data collection (electronic case report forms), Data dictionary (MedDRA)
Interventions
DRUGPHP-201 0.25% ophthalmic solution
3 drops daily, 28 days
DRUGPHP-201 0.5% ophthalmic solution
3 drops daily, 28 days
DRUGPlacebo 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
* 19 years and older, female and male * IOP ≤21 mmHg * Subject showing open angle finding, glaucomatous optic nerve damage and visual field defects * BCVA ≥+0.2
Exclusion criteria
* Subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc) * Subject who can't discontinue contact lenses * Subject who can't discontinue topical/systemic IOP lowering medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean diurnal IOP change | 4 weeks | Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patient with adverse events | 28 days | The number of patient with adverse events including ocular adverse events |
Countries
South Korea
Outcome results
None listed