Back to resultsA Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Over 18 years
- Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Plug placement
Arm Description
Outcomes
Primary Outcome Measures
Intraocular pressure change from baseline (mmHg)
Secondary Outcome Measures
Number of subjects with adverse events
Full Information
NCT ID
NCT00821002
First Posted
January 8, 2009
Last Updated
September 16, 2013
Sponsor
Mati Therapeutics Inc.
Collaborators
QLT Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00821002
Brief Title
A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)
Official Title
An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug 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
November 2009 (Actual)
Study Completion Date
November 2009 (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 study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plug placement
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
Comparison of punctal plug placement between upper and lower puncta
Primary Outcome Measure Information:
Title
Intraocular pressure change from baseline (mmHg)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
6 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
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:
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)
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