Back to resultsA Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
Primary Purpose
Ocular Hypertension, Open-Angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost Punctal Plug Delivery System
Xalatan
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring Ocular Hypertension, Open-Angle Glaucoma, Xalatan, IOP
Eligibility Criteria
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
Sites / Locations
- Menlo Park
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Latanoprost Punctal Plug Delivery System followed by Xalatan
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from baseline in IOP measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT01037036
First Posted
December 17, 2009
Last Updated
December 10, 2013
Sponsor
Mati Therapeutics Inc.
Collaborators
QLT Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01037036
Brief Title
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mati Therapeutics Inc.
Collaborators
QLT Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open-Angle Glaucoma
Keywords
Ocular Hypertension, Open-Angle Glaucoma, Xalatan, IOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latanoprost Punctal Plug Delivery System followed by Xalatan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Latanoprost Punctal Plug Delivery System
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Xalatan
Intervention Description
Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
Primary Outcome Measure Information:
Title
Change from baseline in IOP measurements
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Cuzanni, MD, MSc
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Menlo Park
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
We'll reach out to this number within 24 hrs