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A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study has been completed.
Information provided by (Responsible Party):
Mati Therapeutics Inc. Identifier:
First received: November 25, 2011
Last updated: September 19, 2013
Last verified: September 2013
The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.

Condition Intervention Phase
Ocular Hypertension (OH)
Drug: Latanoprost-PPDS
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Resource links provided by NLM:

Further study details as provided by Mati Therapeutics Inc.:

Primary Outcome Measures:
  • IOP change from baseline [ Time Frame: 12 weeks to baseline ]

Enrollment: 57
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Latanoprost-PPDS
    Sustained delivery for 12 weeks

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 medication conditions
  Contacts and Locations
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Please refer to this study by its identifier: NCT01481051

United States, California
Sall Research Medical Center, Inc
Artesia, California, United States, 90701
Wolstan & Goldberg Eye Associates
Los Angeles, California, United States, 90505
West Coast Eye Care Associates
San Diego, California, United States, 92115
United States, Georgia
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Texas
R and R Eye Associates
San Antonio, Texas, United States, 78229
United States, Utah
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Mati Therapeutics Inc.
Study Director: Suzanne Cadden QLT Inc.
  More Information

Responsible Party: Mati Therapeutics Inc. Identifier: NCT01481051     History of Changes
Other Study ID Numbers: PPL GLAU 12
Study First Received: November 25, 2011
Last Updated: September 19, 2013

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents processed this record on May 25, 2017