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A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229982
First Posted: October 28, 2010
Last Update Posted: September 19, 2013
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.
Information provided by (Responsible Party):
Mati Therapeutics Inc.
  Purpose
The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

Condition Intervention Phase
Ocular Hypertension Open Angle Glaucoma Drug: Latanoprost-PPDS Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Evaluating Safety and Efficacy 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 at 4 weeks [ Time Frame: Baseline to 4 Weeks ]
    4 Weeks minus baseline


Enrollment: 121
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-PPDS Drug: Latanoprost-PPDS
Punctal Plug

  Eligibility

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:

  • Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
  • Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion Criteria:

  • Functionally significant vision loss, or progressive field loss within the last year.
  • Contact lens wear at any time during the treatment period.
  • Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
  • Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
  • Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
  • Currently on chronic ocular topical medications
  • Currently on any ophthalmic or systemic steroid therapy.
  • Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
  • History of macular edema
  • History of chronic/recurrent inflammatory eye disease.
  • History of a non-response to topical prostaglandin therapy.
  • Subjects who have epiphora.
  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): NCT01229982


Locations
Canada, British Columbia
QLT Inc.
Vancouver, British Columbia, Canada, V5T 4T5
Sponsors and Collaborators
Mati Therapeutics Inc.
  More Information

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01229982     History of Changes
Other Study ID Numbers: PPL GLAU 11
First Submitted: October 27, 2010
First Posted: October 28, 2010
Last Update Posted: September 19, 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