Chalazion Conservative Treatment Trial
Primary Purpose
Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hot Compress plus Tobramycin Drops and Ointment
Hot compress plus Tobramycin/Dexamethasone Drops and Ointment
Hot Compresses
Sponsored by
About this trial
This is an interventional treatment trial for Chalazion Unspecified Eye, Unspecified Eyelid
Eligibility Criteria
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
Sites / Locations
- Elmhurst Hospital Center
- Icahn School of Medicine at Mount Sinai
- St. Joseph's Hospital Eye Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Hot Compress
Tobrex
Tobradex
Arm Description
"Hot Compress"
"Hot Compress", "Tobrex Drops", "Tobrex Ointment"
"Hot Compress", "Tobradex Drops", "Tobradex Ointment"
Outcomes
Primary Outcome Measures
Number of Participants With Complete Resolution
Defined as number of patients with chalazion size regression of 100%
Secondary Outcome Measures
Chalazion Size Difference Post-Treatment
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
Full Information
NCT ID
NCT01230593
First Posted
October 27, 2010
Last Updated
June 9, 2018
Sponsor
McMaster University
Collaborators
Icahn School of Medicine at Mount Sinai, Edward-Elmhurst Health System
1. Study Identification
Unique Protocol Identification Number
NCT01230593
Brief Title
Chalazion Conservative Treatment Trial
Official Title
A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Icahn School of Medicine at Mount Sinai, Edward-Elmhurst Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid, Chalazion Both Eyes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hot Compress
Arm Type
Active Comparator
Arm Description
"Hot Compress"
Arm Title
Tobrex
Arm Type
Active Comparator
Arm Description
"Hot Compress", "Tobrex Drops", "Tobrex Ointment"
Arm Title
Tobradex
Arm Type
Active Comparator
Arm Description
"Hot Compress", "Tobradex Drops", "Tobradex Ointment"
Intervention Type
Drug
Intervention Name(s)
Hot Compress plus Tobramycin Drops and Ointment
Other Intervention Name(s)
Aktob, Tobralcon, Tobrasol, Tobramycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Hot compress plus Tobramycin/Dexamethasone Drops and Ointment
Other Intervention Name(s)
Tobramycin/dexamethasone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hot Compresses
Intervention Description
Hot compresses 3x/day to eyelids
Primary Outcome Measure Information:
Title
Number of Participants With Complete Resolution
Description
Defined as number of patients with chalazion size regression of 100%
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Chalazion Size Difference Post-Treatment
Description
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
Time Frame
baseline and 4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Y Wu, M.D., Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
St. Joseph's Hospital Eye Clinic
City
Stoney Creek
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29338124
Citation
Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16.
Results Reference
derived
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Chalazion Conservative Treatment Trial
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