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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-05-02

Brief Summary

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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

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Detailed Description

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

Conditions

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Normal Tension Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PHP-201 0.25% ophthalmic solution

PHP-201 0.25% ophthalmic solution, TID

Group Type EXPERIMENTAL

PHP-201 0.25% ophthalmic solution

Intervention Type DRUG

3 drops daily, 28 days

PHP-201 0.5% ophthalmic solution

PHP-201 0.5% ophthalmic solution, TID

Group Type EXPERIMENTAL

PHP-201 0.5% ophthalmic solution

Intervention Type DRUG

3 drops daily, 28 days

Placebo ophthalmic solution

Placebo ophthalmic solution, TID

Group Type PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type DRUG

3 drops daily, 28 days

Interventions

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PHP-201 0.25% ophthalmic solution

3 drops daily, 28 days

Intervention Type DRUG

PHP-201 0.5% ophthalmic solution

3 drops daily, 28 days

Intervention Type DRUG

Placebo ophthalmic solution

3 drops daily, 28 days

Intervention Type DRUG

Other Intervention Names

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PHP-201 PHP-201 PHP-201

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No