The Retention Rate Between Brand A and Brand B Punctal Plugs

Queen's University

Status: Completed

Conditions: Dry Eye

Treatments: Device: Parasol Punctal Occluder; Device: Superflex Punctal Occluder

Study type: Observational

Funder types: Other

Identifiers

NCT01947517

Punctal plugs

Details and patient eligibility

About

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).

Full 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.

Enrollment: 52 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate dry eye, severe dry eye

Exclusion criteria

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

Trial design

52 participants in 2 patient groups

Parasol Punctal Occluder Group

Description:

Randomized to receive Brand A punctal plugs

Treatment:

Device: Parasol Punctal Occluder

Superflex Punctal Occluder Group

Description:

Randomized to receive Group B punctal plugs

Treatment:

Device: Superflex Punctal Occluder