The Retention Rate Between Brand A and Brand B Punctal Plugs

Moderate to Severe Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01947517
• Other study ID #: Punctal plugs
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2013
• Last updated: September 26, 2013
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2013
• Source: Queen's University
• Contact: Ashley R Brissette, BSc, MD
• Phone: 613 544 3310
• Email: abrissette[@]qmed.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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).

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 weeks. This will be measured at weekly 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• moderate dry eye, severe dry eye

Exclusion Criteria:

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Moderate to Severe Dry Eye

Intervention

Device:
• Parasol Punctal Occluder

• Superflex Punctal Occluder

Locations

Country	Name	City	State
Canada	Department of Ophthalmology, Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of retention		6 months	No
Secondary	Improvement in Canadian Dry Eye Assessment scores		6 months	No
Secondary	Improvement in corneal fluorescein staining		6 months	No
Secondary	Improvement in lissamine green conjunctival staining		6 months	No
Secondary	Improvement in tear meniscus height		6 months	No