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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Edward-Elmhurst Health System | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hot Compress | Active Comparator | "Hot Compress" |
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| Tobrex | Active Comparator | "Hot Compress", "Tobrex Drops", "Tobrex Ointment" |
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| Tobradex | Active Comparator | "Hot Compress", "Tobradex Drops", "Tobradex Ointment" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hot Compress plus Tobramycin Drops and Ointment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Resolution | Defined as number of patients with chalazion size regression of 100% | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Albert Y Wu, M.D., Ph.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States | ||
| Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29338124 | Derived | Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Hot Compress + Tobramycin Drops and Ointment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Hot compress plus Tobramycin/Dexamethasone Drops and Ointment | Drug | 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. |
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| Hot Compresses | Other | Hot compresses 3x/day to eyelids |
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| New York |
| New York |
| 10029 |
| United States |
| St. Joseph's Hospital Eye Clinic | Stoney Creek | Ontario | L8G 5E4 | Canada |
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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Pre-treatment lesion duration (months) | Mean | Standard Deviation | months |
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| Initial lesion size (mm) | Mean | Standard Deviation | millimeters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Complete Resolution | Defined as number of patients with chalazion size regression of 100% | Intention to treat population | Posted | Number | participants | 4-6 weeks |
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| Secondary | Chalazion Size Difference Post-Treatment | Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment | Intention to treat population | Posted | Mean | Standard Deviation | millimeters | baseline and 4-6 weeks |
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Adverse events were monitored over a time frame of 4-6 weeks from baseline enrollment of each participant. Participants returned for follow-up between 4 and 6 weeks after starting treatment.
Serious Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 50 | 0 | 50 | ||
| EG001 | Hot Compress, Tobrex Drops, Tobrex 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. | 0 | 50 | 0 | 50 | ||
| EG002 | Hot Compress, Tobradex Drops, Tobradex 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. | 0 | 50 | 0 | 50 |
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Large loss to follow-up - only 70% completed follow-up - was a limitation.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albert Wu MD PhD | Icahn School of Medicine at Mount Sinai | 2125184524 | albert.wu@mssm.edu |
| ID | Term |
|---|---|
| D009824 | Ointments |
| D014031 | Tobramycin |
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003907 | Dexamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004338 | Drug Combinations |
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| Male |
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| United States |
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