Back to resultsA Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost-PPDS
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Over 18 yrs with ocular hypertension or open-angle glaucoma
- Subjects who have a best-corrected visual acuity of 20/100 or better.
Exclusion Criteria:
- Subjects who wear contact lenses.
- Uncontrolled medical conditions
- Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
- Subjects who have a history of chronic or recurrent inflammatory eye disease.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Punctal plug
Arm Description
Outcomes
Primary Outcome Measures
IOP change from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00820300
First Posted
January 8, 2009
Last Updated
September 16, 2013
Sponsor
Mati Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00820300
Brief Title
A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mati Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Punctal plug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Latanoprost-PPDS
Intervention Description
Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.
Primary Outcome Measure Information:
Title
IOP change from baseline
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 yrs with ocular hypertension or open-angle glaucoma
Subjects who have a best-corrected visual acuity of 20/100 or better.
Exclusion Criteria:
Subjects who wear contact lenses.
Uncontrolled medical conditions
Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
Subjects who have a history of chronic or recurrent inflammatory eye disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Cuzzani, MD
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
Facility Information:
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
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