The Retention Rate Between Brand A and Brand B Punctal Plugs

Completed

• Conditions: Dry Eye
• Interventions: Device: Superflex Punctal Occluder; Device: Parasol Punctal Occluder

• Registration Number: NCT01947517
• Lead Sponsor: Queen's University

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).

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Results First Submitted: 2015-10-01
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Results First Posted: 2017-06-16
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• moderate dry eye, severe dry eye

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Superflex Punctal Occluder Group	Superflex Punctal Occluder	Randomized to receive Group B punctal plugs
Parasol Punctal Occluder Group	Parasol Punctal Occluder	Randomized to receive Brand A punctal plugs

Primary Outcome Measures

Name	Time	Method
Length of Retention	6 months

Secondary Outcome Measures

Name	Time	Method
National Eye Institute Grading for Conjunctival Staining	6 months	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.
National Eye Institute Corneal Fluorescein Staining Pattern	6 months	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.
Canadian Dry Eye Assessment Score	6 months	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.
Tear Meniscus Height	6 months	Meniscus height measured in mm

Trial Locations

Locations (1)

Department of Ophthalmology, Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada