Evaluation of PHP-201 Ophthalmic Solution in Patients With Normal Tension Glaucoma

pH Pharma119 enrolled

Overview

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

Data collection (electronic case report forms), Data dictionary (MedDRA)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

119

Conditions

Normal Tension Glaucoma

Interventions

PHP-201 0.25% ophthalmic solutionDRUG

3 drops daily, 28 days

PHP-201 0.5% ophthalmic solutionDRUG

3 drops daily, 28 days

Placebo ophthalmic solutionDRUG

3 drops daily, 28 days

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Mean diurnal IOP change

Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks

Time frame: 4 weeks

Secondary Outcomes

The number of patient with adverse events

The number of patient with adverse events including ocular adverse events

Time frame: 28 days

Data from ClinicalTrials.gov

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