Chalazion Conservative Treatment Trial

Not Applicable

Completed

• Conditions: Chalazion Both Eyes; Chalazion Unspecified Eye, Unspecified Eyelid; Chalazion Right Eye, Unspecified Eyelid; Chalazion Left Eye, Unspecified Eyelid
• Interventions: Drug: Hot Compress plus Tobramycin Drops and Ointment; Other: Hot Compresses; Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment

• Registration Number: NCT01230593
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Study Start: 2010-11
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Results First Submitted: 2017-04-04
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-09
• Last Update Submitted: 2018-06-09
• Results First Posted: 2018-06-12
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tobrex	Hot Compress plus Tobramycin Drops and Ointment	"Hot Compress", "Tobrex Drops", "Tobrex Ointment"
Hot Compress	Hot Compresses	"Hot Compress"
Tobradex	Hot compress plus Tobramycin/Dexamethasone Drops and Ointment	"Hot Compress", "Tobradex Drops", "Tobradex Ointment"

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Resolution	4-6 weeks	Defined as number of patients with chalazion size regression of 100%

Secondary Outcome Measures

Name	Time	Method
Chalazion Size Difference Post-Treatment	baseline and 4-6 weeks	Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment

Trial Locations

Locations (3)

St. Joseph's Hospital Eye Clinic; 🇨🇦 Stoney Creek, Ontario, Canada

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Elmhurst Hospital Center; 🇺🇸 Elmhurst, New York, United States