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Sponsors and Collaborators: |
QLT Plug Delivery, Inc. QLT Inc |
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Information provided by: | QLT Plug Delivery, Inc. |
ClinicalTrials.gov Identifier: | NCT00821002 |
The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).
Condition | Intervention | Phase |
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Open-Angle Glaucoma Ocular Hypertension |
Drug: Latanoprost |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG) |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Plug placement: Experimental |
Drug: Latanoprost
Comparison of punctal plug placement between upper and lower puncta
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sue-Anne Crocker | 1-800-663-5486 | medaffairs@qltinc.com |
United States, Missouri | |
Recruiting | |
Des Peres, Missouri, United States, 63131 |
Study Director: | Oscar Cuzanni, MD, MSc | QLT Inc |
Responsible Party: | QLT Inc., ( Study Manager ) |
Study ID Numbers: | PPL GLAU 05 |
Study First Received: | January 8, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00821002 |
Health Authority: | United States: Food and Drug Administration |
Glaucoma |
Glaucoma Eye Diseases Glaucoma, Open-Angle Vascular Diseases |
Latanoprost Hypertension Ocular Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |