Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Verified by: QLT Inc, March 2011
First Received: March 27, 2008 | Last Updated: March 25, 2011 | Phase: Phase 2 | Start Date: March 2008
Overall Status: Completed | Estimated Enrollment: 36
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: QLT Inc Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00650702