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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01481051
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension (OH) Drug: Latanoprost-PPDS Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : November 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Latanoprost-PPDS
    Sustained delivery for 12 weeks

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481051


Locations
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.
Investigators
Study Director: Suzanne Cadden QLT Inc.
More Information

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01481051     History of Changes
Other Study ID Numbers: PPL GLAU 12
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents