The Retention Rate Between Brand A and Brand B Punctal Plugs

NCT ID: NCT01947517

Last Updated: 2017-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parasol Punctal Occluder Group

Randomized to receive Brand A punctal plugs

Parasol Punctal Occluder

Intervention Type DEVICE

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

Superflex Punctal Occluder

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parasol Punctal Occluder

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

Intervention Type DEVICE

Superflex Punctal Occluder

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* moderate dry eye, severe dry eye

Exclusion Criteria

* silicone allergy, punctal stenosis, punctal occlusion, punctal cautery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Queen's University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Stephanie Baxter

Program Director Department of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ashley R Brissette, BSc, MD

Role: STUDY_DIRECTOR

Queens University

Stephanie Baxter, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queens University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Punctal plugs

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.