NCT01947517

The Retention Rate Between Brand A and Brand B Punctal Plugs

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	Parasol Punctal Occluder	Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
DEVICE	Superflex Punctal Occluder	Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-05-01
• Completion: 2014-08-01
• First posted: 2013-09-20
• Last updated: 2017-06-16
• Results posted: 2017-06-16

Locations

1 site across 1 country: Canada