A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
1 other identifier
interventional
77
1 country
11
Brief Summary
The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2011
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedSeptember 26, 2013
September 1, 2013
10 months
November 25, 2011
September 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
IOP change from baseline
12 weeks to baseline
Study Arms (3)
Treatment A
EXPERIMENTALTreatment B
EXPERIMENTALTreatment C
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female at least 18 years old
- Diagnosis of bilateral open angle glaucoma or ocular hypertension
- Unmedicated IOP must be ≥22mm Hg
You may not qualify if:
- 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 medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Vold Vision
Springdale, Arkansas, 72762, United States
Glaucoma Consultants of Colorado, PC
Denver, Colorado, 80134, United States
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810, United States
Ophthalmology Consultants Inc.
Des Peres, Missouri, 63131, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Comprehensive Eye Care, Ltd
Washington, Missouri, 63090, United States
Las Vegas Physicians Research Group
Henderson, Nevada, 89052, United States
Abrams Eye Institute
Las Vegas, Nevada, 89148, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148, United States
University Eye Surgeons
Maryville, Tennessee, 37803, United States
Total Eye Care, P.A.
Memphis, Tennessee, 38119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Suzanne Cadden
QLT Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2011
First Posted
November 29, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
September 26, 2013
Record last verified: 2013-09