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Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension (CORE)

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: NCT00650702
Recruitment Status : Completed
First Posted : April 2, 2008
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Low Latanoprost-PPDS
 Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Experimental: 2
Medium Latanoprost-PPDS
 Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Experimental: 3
High Latanoprost-PPDS
 Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy


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

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Over 18 yrs with open-angle glaucoma or ocular hypertension
  • Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

  • Uncontrolled medical conditions.
  • Subjects who wear contact lenses.
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
  • Subjects who have a history of chronic or recurrent inflammatory eye disease.
Contacts and Locations
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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): NCT00650702


Locations
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United States, California
Artesia, California, United States, 90701
Sacramento, California, United States, 95815
United States, Maryland
Bel Air, Maryland, United States, 21014
United States, Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Missouri
St. Louis, Missouri, United States, 63131
United States, New York
Lynbrook, New York, United States, 11563
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Mati Therapeutics Inc.
More Information
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Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00650702    
Other Study ID Numbers: PPL GLAU 02
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: March 2011
Keywords provided by Mati Therapeutics Inc.:
glaucoma, ocular hypertension, IOP
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions