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

October 25, 2018 updated by: pH Pharma

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

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

Study Overview

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PHP-201 0.25% ophthalmic solution
PHP-201 0.25% ophthalmic solution, TID
3 drops daily, 28 days
Other Names:
  • PHP-201
EXPERIMENTAL: PHP-201 0.5% ophthalmic solution
PHP-201 0.5% ophthalmic solution, TID
3 drops daily, 28 days
Other Names:
  • PHP-201
PLACEBO_COMPARATOR: Placebo ophthalmic solution
Placebo ophthalmic solution, TID
3 drops daily, 28 days
Other Names:
  • PHP-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean diurnal IOP change
Time Frame: 4 weeks
Mean diurnal IOP change from baseline at post-treatment time point of 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patient with adverse events
Time Frame: 28 days
The number of patient with adverse events including ocular adverse events
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2017

Primary Completion (ACTUAL)

May 2, 2018

Study Completion (ACTUAL)

May 2, 2018

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (ACTUAL)

April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Normal Tension Glaucoma

Clinical Trials on PHP-201 0.25% ophthalmic solution

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