Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension (CORE)

September 16, 2013 updated by: Mati Therapeutics Inc.

A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • United States
    • California
      • Artesia, California, United States, 90701
      • Sacramento, California, United States, 95815
    • Maryland
      • Bel Air, Maryland, United States, 21014
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • St. Louis, Missouri, United States, 63131
    • New York
      • Lynbrook, New York, United States, 11563
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19148

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 yrs with open-angle glaucoma or ocular hypertension
  • Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

  • Uncontrolled medical conditions.
  • Subjects who wear contact lenses.
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
  • Subjects who have a history of chronic or recurrent inflammatory eye disease.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Low Latanoprost-PPDS
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Experimental: 2
Medium Latanoprost-PPDS
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Experimental: 3
High Latanoprost-PPDS
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP change from baseline
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

Mati Therapeutics Inc.

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

March 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPL GLAU 02

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.

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