Chalazion Conservative Treatment Trial

McMaster University

Status: Completed

Conditions: Chalazion Both Eyes; Chalazion Left Eye, Unspecified Eyelid; Chalazion Right Eye, Unspecified Eyelid; Chalazion Unspecified Eye, Unspecified Eyelid

Treatments: Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment; Other: Hot Compresses; Drug: Hot Compress plus Tobramycin Drops and Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01230593

10-469

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Hot Compress

Active Comparator group

Description:

"Hot Compress"

Treatment:

Other: Hot Compresses

Tobrex

Active Comparator group

Description:

"Hot Compress", "Tobrex Drops", "Tobrex Ointment"

Treatment:

Drug: Hot Compress plus Tobramycin Drops and Ointment

Tobradex

Active Comparator group

Description:

"Hot Compress", "Tobradex Drops", "Tobradex Ointment"

Treatment:

Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment