Chalazion Conservative Treatment Trial

June 9, 2018 updated by: Albert Wu, McMaster University

A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments

An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Stoney Creek, Ontario, Canada, L8G 5E4
        • St. Joseph's Hospital Eye Clinic
  • United States
    • New York
      • Elmhurst, New York, United States, 11373
        • Elmhurst Hospital Center
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients age 18 and above
  • Patient with a palpable chalazion on any eyelid
  • Patients with multiple chalazia but only a single one on each lid
  • Normal lid anatomy enabling lid eversion

Exclusion Criteria

  • Patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy
  • Patients allergic to any agents being used in the study (tobramycin, dexamethasone)
  • Patients who have had previous eyelid surgery to the same eyelid as the chalazion
  • Patients under 18 years of age
  • Patients without palpable lid chalazion
  • Patients with multiple chalazia on one eyelid
  • Patients with concurrent eyelid infection (cellulitis or conjunctivitis)
  • Patients unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hot Compress
"Hot Compress"
Other: Hot Compresses
Hot compresses 3x/day to eyelids
Active Comparator: Tobrex
"Hot Compress", "Tobrex Drops", "Tobrex Ointment"
Drug: Hot Compress plus Tobramycin Drops and Ointment
In addition to hot compress, Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
Other Names:
  • Aktob
  • Tobralcon
  • Tobrasol
  • Tobramycin
Active Comparator: Tobradex
"Hot Compress", "Tobradex Drops", "Tobradex Ointment"
Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment
In addition to hot compress, Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
Other Names:
  • Tobramycin/dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Resolution
Time Frame: 4-6 weeks
Defined as number of patients with chalazion size regression of 100%
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chalazion Size Difference Post-Treatment
Time Frame: baseline and 4-6 weeks
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
baseline and 4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Icahn School of Medicine at Mount Sinai
Edward-Elmhurst Health System

Investigators

  • Principal Investigator: Albert Y Wu, M.D., Ph.D., ICAHN School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 27, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 9, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-469

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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