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A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
This study is currently recruiting participants.
Verified by QLT Plug Delivery, Inc., January 2009
Sponsored by: QLT Plug Delivery, Inc.
Information provided by: QLT Plug Delivery, Inc. Identifier: NCT00820300

The purpose of this study is to determine if the Punctal Plug Delivery System is safe and effective in controlling intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Condition Intervention Phase
Ocular Hypertension
Drug: Latanoprost-PPDS
Phase II

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma High Blood Pressure
Drug Information available for: Latanoprost BaseLine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)

Further study details as provided by QLT Plug Delivery, Inc.:

Primary Outcome Measures:
  • IOP change from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Punctal plug: Experimental Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 4 months or until loss of efficacy.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Over 18 yrs with ocular hypertension or open-angle glaucoma
  • Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

  • Subjects who wear contact lenses.
  • Uncontrolled medical conditions
  • 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00820300

Contact: Oscar Cuzzani, MD 1-800-663-5486

United States, Missouri
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
QLT Plug Delivery, Inc.
Study Director: Oscar Cuzzani, MD QLT Inc
  More Information

Responsible Party: QLT Inc. ( Study Manager )
Study ID Numbers: PPL GLAU 03
Study First Received: January 8, 2009
Last Updated: January 9, 2009 Identifier: NCT00820300  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Ocular Hypertension

Additional relevant MeSH terms:
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions processed this record on January 13, 2009