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OpenTrials
Completed

NCT Number: NCT03106532

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

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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Key information

Conditions

Normal Tension Glaucoma Eye Diseases Glaucoma Low Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHP-201 0.25% ophthalmic solution

Drug

3 drops daily, 28 days

Other names: PHP-201

PHP-201 0.5% ophthalmic solution

Drug

3 drops daily, 28 days

Other names: PHP-201

Placebo Ophthalmic Solution

Drug

3 drops daily, 28 days

Other names: PHP-201

Primary outcomes

  1. Mean diurnal IOP change

    Time frame: 4 weeks

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

Secondary outcomes

  1. The number of patient with adverse events

    Time frame: 28 days

    The number of patient with adverse events including ocular adverse events

Sponsors and collaborators

Lead sponsor

pH Pharma

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 2 Clinical Trial to Evaluate the Efficacy in Reduction of Intraocular Pressure and Safety of PHP-201 in Patients With Normal Tension Glaucoma

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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