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:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01229982
First received: October 27, 2010
Last updated: September 16, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01229982

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

No publications provided

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01229982     History of Changes
Other Study ID Numbers: PPL GLAU 11
Study First Received: October 27, 2010
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

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 24, 2014