The Retention Rate Between Brand A and Brand B Punctal Plugs

The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Parasol Punctal Occluder; Device: Superflex Punctal Occluder

Detailed Description

Eyes will be randomized to either Brand A or Brand B punctal plug. The primary outcome measure is length of time punctual plugs are retained, measured in months. This will be measured at monthly assessments for 6 months. Secondary outcome measures include patient satisfaction, and improvement in subjective and objective dry eye scores, as well as complications related to punctual plugs including spontaneous plug loss, and intolerance. We will evaluate these measures by repeating the Canadian Dry Eye Assessment, Schirmer 1, tear meniscus height, fluorescein corneal staining (NEI scale), and lissamine green conjunctival staining (NEI scale) at month 1, month 3, and month 6 visits.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Department of Ophthalmology, Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University

Description

Inclusion Criteria:

• moderate dry eye, severe dry eye

Exclusion Criteria:

• silicone allergy, punctal stenosis, punctal occlusion, punctal cautery

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parasol Punctal Occluder Group; Randomized to receive Brand A punctal plugs	Device: Parasol Punctal Occluder; Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
Superflex Punctal Occluder Group; Randomized to receive Group B punctal plugs	Device: Superflex Punctal Occluder; Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of Retention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Dry Eye Assessment Score	Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.	6 months
National Eye Institute Corneal Fluorescein Staining Pattern	The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.	6 months
National Eye Institute Grading for Conjunctival Staining	The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.	6 months
Tear Meniscus Height	Meniscus height measured in mm	6 months

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Study Director: Ashley R Brissette, BSc, MD, Queens University; Principal Investigator: Stephanie Baxter, MD, FRCSC, Queens University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: Punctal plugs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No