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Completed

NCT Number: NCT01947517

The Retention Rate Between Brand A and Brand B Punctal Plugs

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).

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate dry eye, severe dry eye

Exclusion criteria

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

Treatment and study plan

Parasol Punctal Occluder

Device

Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.

Superflex Punctal Occluder

Device

Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.

Primary outcomes

  1. Length of Retention

    Time frame: 6 months

Secondary outcomes

  1. Canadian Dry Eye Assessment Score

    Time frame: 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.

  2. National Eye Institute Corneal Fluorescein Staining Pattern

    Time frame: 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.

  3. National Eye Institute Grading for Conjunctival Staining

    Time frame: 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.

  4. Tear Meniscus Height

    Time frame: 6 months

    Meniscus height measured in mm

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 20, 2013
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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