N/A
N=150
Chalazion Conservative Treatment Trial
Chalazion Unspecified Eye, Unspecified Eyelid · Chalazion Left Eye, Unspecified Eyelid · Chalazion Right Eye, Unspecified Eyelid · Chalazion Both Eyes
Bottom Line
View on ClinicalTrials.gov: NCT01230593 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Complete Resolution — 13; 12; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hot Compress plus Tobramycin Drops and Ointment (Drug); Hot compress plus Tobramycin/Dexamethasone Drops and Ointment (Drug); Hot Compresses (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- McMaster University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Resolution |
13; 12; 11 | — |
| SECONDARY Chalazion Size Difference Post-Treatment |
1.20; 1.69; 1.54 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01230593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.