Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Retention Rate Between Brand A and Brand B Punctal Plugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01947517
Recruitment Status : Completed
First Posted : September 20, 2013
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Stephanie Baxter, Queen's University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Dry Eye Device: Parasol Punctal Occluder Device: Superflex Punctal Occluder

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Retention Rate Between Superflex Punctal Plugs, and Parasol Punctal Occluders
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Parasol Punctal Occluder Group
Randomized to receive Brand A punctal plugs
 Device: Parasol Punctal Occluder
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
Superflex Punctal Occluder Group
Randomized to receive Group B punctal plugs
 Device: Superflex Punctal Occluder
Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Length of Retention [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be recruited from cornea and general ophthalmology specialist practices at Hotel Dieu Hospital, Queens University
Criteria

Inclusion Criteria:

  • moderate dry eye, severe dry eye

Exclusion Criteria:

  • silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947517


Locations
Layout table for location information
Canada, Ontario
Department of Ophthalmology, Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Layout table for investigator information
Study Director: Ashley R Brissette, BSc, MD Queens University
Principal Investigator: Stephanie Baxter, MD, FRCSC Queens University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Stephanie Baxter, Program Director Department of Ophthalmology, Queen's University
ClinicalTrials.gov Identifier: NCT01947517    
Other Study ID Numbers: Punctal plugs
First Posted: September 20, 2013    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases