- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037036
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
December 10, 2013 updated by: Mati Therapeutics Inc.
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)
The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Menlo Park, California, United States, 94025
- Menlo Park
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years
- Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
- Currently on prostaglandin therapy
Exclusion Criteria:
- Uncontrolled medical conditions
- Subjects who wear contact lenses
- Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in IOP measurements
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Oscar Cuzanni, MD, MSc, QLT Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
December 18, 2009
First Posted (Estimate)
December 21, 2009
Study Record Updates
Last Update Posted (Estimate)
January 10, 2014
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPL GLAU 08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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