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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

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ClinicalTrials.gov Identifier: NCT01481077
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension (OH) Drug: Latanoprost-PPDS Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2011
Actual Primary Completion Date : September 2012
Actual 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

Arm Intervention/treatment
Experimental: Treatment A Drug: Latanoprost-PPDS
Sustained release for 12 weeks
Experimental: Treatment B Drug: Latanoprost-PPDS
Sustained release for 12 weeks
Experimental: Treatment C Drug: Latanoprost-PPDS
Sustained release for 12 weeks



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


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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 medical conditions

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): NCT01481077


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

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01481077     History of Changes
Other Study ID Numbers: PPL GLAU 13
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