A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
Sponsor
Mati Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00820300
Collaborator
(none)
113
1
1
11
10.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
113 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Punctal plug
|
Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.
|
Outcome Measures
Primary Outcome Measures
- IOP change from baseline [6 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Menlo Park | California | United States | 94025 |
Sponsors and Collaborators
- Mati Therapeutics Inc.
Investigators
- Study Director: Oscar Cuzzani, MD, QLT Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00820300
Other Study ID Numbers:
- PPL GLAU 03
First Posted:
Jan 12, 2009
Last Update Posted:
Sep 19, 2013
Last Verified:
Sep 1, 2013
Additional relevant MeSH terms: