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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00650702
First received: March 27, 2008
Last updated: September 16, 2013
Last verified: March 2011
  Purpose

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 Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Latanoprost-PPDS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00650702

Locations
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

No publications provided

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00650702     History of Changes
Other Study ID Numbers: PPL GLAU 02
Study First Received: March 27, 2008
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mati Therapeutics Inc.:
glaucoma, ocular hypertension, IOP

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

ClinicalTrials.gov processed this record on July 22, 2014