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Study 18 of 2219 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
QLT Plug Delivery, Inc. |
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Information provided by: | QLT Plug Delivery, Inc. |
ClinicalTrials.gov 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 |
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Glaucoma Ocular Hypertension |
Drug: Latanoprost-PPDS |
Phase II |
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) |
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 |
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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.
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Oscar Cuzzani, MD | 1-800-663-5486 | ocuzzani@qltinc.com |
United States, Missouri | |
Recruiting | |
St. Louis, Missouri, United States, 63131 |
Study Director: | Oscar Cuzzani, MD | QLT Inc |
Responsible Party: | QLT Inc. ( Study Manager ) |
Study ID Numbers: | PPL GLAU 03 |
Study First Received: | January 8, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820300 |
Health Authority: | United States: Food and Drug Administration |
Glaucoma Eye Diseases Glaucoma, Open-Angle Vascular Diseases |
Latanoprost Hypertension Ocular Hypertension |
Therapeutic Uses Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |