A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01037036|
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : January 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Open-Angle Glaucoma||Drug: Latanoprost Punctal Plug Delivery System Drug: Xalatan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||July 2010|
Experimental: Latanoprost Punctal Plug Delivery System followed by Xalatan
Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
Drug: Latanoprost Punctal Plug Delivery System
To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.
Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
- Change from baseline in IOP measurements [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037036
|United States, California|
|Menlo Park, California, United States, 94025|
|Study Director:||Oscar Cuzanni, MD, MSc||QLT Inc.|