Chalazion Conservative Treatment Trial

Chalazion Both Eyes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230593
• Other study ID #: 10-469
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: March 2016

Study information

• Verified date: June 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chalazion
• Chalazion Both Eyes
• Chalazion Left Eye, Unspecified Eyelid
• Chalazion Right Eye, Unspecified Eyelid
• Chalazion Unspecified Eye, Unspecified Eyelid

Intervention

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.
• 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:
• Hot Compresses
Hot compresses 3x/day to eyelids

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital Eye Clinic	Stoney Creek	Ontario
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Edward-Elmhurst Health System, Icahn School of Medicine at Mount Sinai

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Resolution	Defined as number of patients with chalazion size regression of 100%	4-6 weeks
Secondary	Chalazion Size Difference Post-Treatment	Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment	baseline and 4-6 weeks