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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Latanoprost-PPDS
  • Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
• Drug: Latanoprost-PPDS
  • Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
• Drug: Latanoprost-PPDS
  • Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Low Latanoprost-PPDS
• Experimental: 2
  • Medium Latanoprost-PPDS
• Experimental: 3
  • High Latanoprost-PPDS

Primary Measures

• IOP change from baseline
  • Time Frame: 12 Weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: QLT Plug Delivery, Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650702

Study ID Number: PPL GLAU 02

ClinicalTrials.gov Identifier: NCT00650702

Health Authority: United States: Food and Drug Administration