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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:
Information provided by (Responsible Party):
QLT Inc.
ClinicalTrials.gov Identifier:
NCT01229982
First received: October 27, 2010
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by QLT 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


Estimated Enrollment: 60
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
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
QLT Inc.
  More Information

No publications provided

Responsible Party: QLT Inc.
ClinicalTrials.gov Identifier: NCT01229982     History of Changes
Other Study ID Numbers: PPL GLAU 11
Study First Received: October 27, 2010
Last Updated: September 14, 2011
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 June 17, 2013