A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
This study has been completed.
Information provided by:
First received: January 8, 2009
Last updated: March 25, 2011
Last verified: March 2011
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
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:||January 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: Punctal plug||
Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.
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