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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01481077
First received: November 25, 2011
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

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 ] [ Designated as safety issue: Yes ]

Enrollment: 77
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01481077     History of Changes
Other Study ID Numbers: PPL GLAU 13
Study First Received: November 25, 2011
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014