A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

September 19, 2013 updated by: Mati Therapeutics Inc.

PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

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
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Vold Vision
    • Colorado
      • Denver, Colorado, United States, 80134
        • Glaucoma Consultants of Colorado, PC
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Eye Physicians & Surgeons
    • Missouri
      • Des Peres, Missouri, United States, 63131
        • Ophthalmology Consultants Inc.
      • St. Louis, Missouri, United States, 63131
        • Ophthalmology Associates
      • Washington, Missouri, United States, 63090
        • Comprehensive Eye Care, Ltd
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Las Vegas Physicians Research Group
      • Las Vegas, Nevada, United States, 89148
        • Abrams Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19148
        • Philadelphia Eye Associates
    • Tennessee
      • Maryville, Tennessee, United States, 37803
        • University Eye Surgeons
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, P.A.

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:

  • Male or female at least 18 years old
  • Diagnosis of bilateral open angle glaucoma or ocular hypertension
  • Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria:

  • Any significant vision loss in the last year
  • No contact lens use for the length of the study
  • Abnormal eye lids, eye infection or diseases to the eye
  • Recent eye surgery
  • Uncontrolled medical conditions

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment B
Drug: Latanoprost-PPDS
Sustained release for 12 weeks
EXPERIMENTAL: Treatment C
Drug: Latanoprost-PPDS
Sustained release for 12 weeks
EXPERIMENTAL: Treatment A
Drug: Latanoprost-PPDS
Sustained release for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP change from baseline
Time Frame: 12 weeks to baseline
12 weeks to baseline

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

November 1, 2011

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (ESTIMATE)

November 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPL GLAU 13

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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