Chalazion Both Eyes, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid, Chalazion Unspecified Eye, Unspecified Eyelid
Conditions
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.
Interventions
DRUGHot 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.
DRUGHot 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.
OTHERHot Compresses
Hot compresses 3x/day to eyelids
Sponsors
Icahn School of Medicine at Mount Sinai
Edward-Elmhurst Health System
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Resolution | 4-6 weeks | Defined as number of patients with chalazion size regression of 100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hot Compress Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.
Hot Compresses: Hot compresses 3x/day to eyelids | 50 |
| Hot Compress + Tobramycin Drops and Ointment In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.
Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed. | 50 |
| Hot Compress + Tobramycin/Dexamethasone Drops and Ointment In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.
Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed. | 49 |
| Total | 149 |
Baseline characteristics
| Characteristic | Hot Compress | Hot Compress + Tobramycin Drops and Ointment | Hot Compress + Tobramycin/Dexamethasone Drops and Ointment | Total |
|---|---|---|---|---|
| Age, Continuous | 45.50 years STANDARD_DEVIATION 15 | 46.42 years STANDARD_DEVIATION 19 | 47.52 years STANDARD_DEVIATION 17 | 47.41 years STANDARD_DEVIATION 17 |
| Initial lesion size (mm) | 6.05 millimeters STANDARD_DEVIATION 3 | 6.16 millimeters STANDARD_DEVIATION 3 | 6.38 millimeters STANDARD_DEVIATION 3 | 6.19 millimeters STANDARD_DEVIATION 3 |
| Pre-treatment lesion duration (months) | 3.55 months STANDARD_DEVIATION 6 | 2.88 months STANDARD_DEVIATION 3 | 5.72 months STANDARD_DEVIATION 13 | 3.96 months STANDARD_DEVIATION 8 |
| Region of Enrollment Canada | 8 participants | 5 participants | 14 participants | 27 participants |
| Region of Enrollment United States | 42 participants | 45 participants | 35 participants | 122 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 30 Participants | 79 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 19 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Number of Participants With Complete Resolution
Defined as number of patients with chalazion size regression of 100%
Time frame: 4-6 weeks
Population: Intention to treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hot Compress | Number of Participants With Complete Resolution | 13 participants |
| Hot Compress + Tobramycin Drops and Ointment | Number of Participants With Complete Resolution | 12 participants |
| Hot Compress + Tobramycin/Dexamethasone Drops and Ointment | Number of Participants With Complete Resolution | 11 participants |
Secondary
Chalazion Size Difference Post-Treatment
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
Time frame: baseline and 4-6 weeks
Population: Intention to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hot Compress | Chalazion Size Difference Post-Treatment | 1.20 millimeters | Standard Deviation 3 |
| Hot Compress + Tobramycin Drops and Ointment | Chalazion Size Difference Post-Treatment | 1.69 millimeters | Standard Deviation 3 |
| Hot Compress + Tobramycin/Dexamethasone Drops and Ointment | Chalazion Size Difference Post-Treatment | 1.54 millimeters | Standard Deviation 3 |