- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01481051
A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
September 19, 2013 updated by: Mati Therapeutics Inc.
PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
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
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California
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Artesia, California, United States, 90701
- Sall Research Medical Center, Inc
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Los Angeles, California, United States, 90505
- Wolstan & Goldberg Eye Associates
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San Diego, California, United States, 92115
- West Coast Eye Care Associates
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Georgia
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Roswell, Georgia, United States, 30076
- Coastal Research Associates, LLC
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Texas
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San Antonio, Texas, United States, 78229
- R and R Eye Associates
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Utah
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Salt Lake City, Utah, United States, 84107
- Rocky Mountain Eye Care Associates
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-
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:
- Male or female at least 18 years old
- Diagnosis of bilateral open angle glaucoma or ocular hypertension
- Unmedicated IOP must be ≥22mm Hg
Exclusion Criteria:
- Any significant vision loss in the last year
- No contact lens use for the length of the study
- Abnormal eye lids, eye infection, or diseases to the eye
- Recent eye surgery
- Uncontrolled medication conditions
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)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IOP change from baseline
Time Frame: 12 weeks to baseline
|
12 weeks to baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
November 25, 2011
First Submitted That Met QC Criteria
November 25, 2011
First Posted (Estimate)
November 29, 2011
Study Record Updates
Last Update Posted (Estimate)
September 26, 2013
Last Update Submitted That Met QC Criteria
September 19, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPL GLAU 12
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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Mati Therapeutics Inc.CompletedOcular Hypertension | GlaucomaUnited States
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Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedPrimary Open Angle Glaucoma | Ocular HypertensionUnited Kingdom, France, Australia, Thailand, Portugal, Pakistan, Czechia, Greece
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Inotek Pharmaceuticals CorporationCompletedOcular Hypertension (OHT) | Primary Open-Angle Glaucoma (POAG)United States