The Retention Rate Between Brand A and Brand B Punctal Plugs
The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders
1 other identifier
observational
52
1 country
1
Brief Summary
The purpose of this study is to determine if Parasol punctal occluders (Brand A) have a higher rate of retention than Superflex punctal plugs (Brand B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
June 16, 2017
CompletedJune 16, 2017
March 1, 2017
8 months
September 17, 2013
October 1, 2015
March 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Retention
6 months
Secondary Outcomes (4)
Canadian Dry Eye Assessment Score
6 months
National Eye Institute Corneal Fluorescein Staining Pattern
6 months
National Eye Institute Grading for Conjunctival Staining
6 months
Tear Meniscus Height
6 months
Study Arms (2)
Parasol Punctal Occluder Group
Randomized to receive Brand A punctal plugs
Superflex Punctal Occluder Group
Randomized to receive Group B punctal plugs
Interventions
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
Eligibility Criteria
Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University
You may qualify if:
- moderate dry eye, severe dry eye
You may not qualify if:
- silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Ophthalmology, Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Stephanie Baxter
- Organization
- Queen's University
Study Officials
- STUDY DIRECTOR
Ashley R Brissette, BSc, MD
Queens University
- PRINCIPAL INVESTIGATOR
Stephanie Baxter, MD, FRCSC
Queens University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director Department of Ophthalmology
Study Record Dates
First Submitted
September 17, 2013
First Posted
September 20, 2013
Study Start
September 1, 2013
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
June 16, 2017
Results First Posted
June 16, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share