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

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. Identifier: NCT01229982
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : September 19, 2013
Information provided by (Responsible Party):
Mati Therapeutics Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Ocular Hypertension Open Angle Glaucoma Drug: Latanoprost-PPDS Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
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)
Study Start Date : October 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: L-PPDS Drug: Latanoprost-PPDS
Punctal Plug

Primary Outcome Measures :
  1. IOP change from baseline at 4 weeks [ Time Frame: Baseline to 4 Weeks ]
    4 Weeks minus baseline

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

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.

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 identifier (NCT number): NCT01229982

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

Responsible Party: Mati Therapeutics Inc. Identifier: NCT01229982     History of Changes
Other Study ID Numbers: PPL GLAU 11
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Antihypertensive Agents