A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma
This study has been withdrawn prior to enrollment.
Information provided by:
First received: March 2, 2009
Last updated: March 1, 2011
Last verified: March 2011
The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by QLT Inc.:
Primary Outcome Measures:
- IOP change from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Experimental: Punctal Plug||
Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
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