Chalazion Conservative Treatment Trial

Study Overview
=================
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.

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

Conditions
-----------------
Chalazion Unspecified Eye, Unspecified Eyelid, Chalazion Left Eye, Unspecified Eyelid, Chalazion Right Eye, Unspecified Eyelid, Chalazion Both Eyes

Intervention / Treatment
-----------------
* Drug: Hot Compress plus Tobramycin Drops and Ointment
* Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment
* Other: Hot Compresses


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hot Compress<br>Hot Compress | Other: Hot Compresses<br>* Hot compresses 3x/day to eyelids<br>|
| Active Comparator: Tobrex<br>Hot Compress, Tobrex Drops, Tobrex Ointment | Drug: Hot Compress plus Tobramycin Drops and Ointment<br>* 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.<br>* Other names: Tobramycin;|
| Active Comparator: Tobradex<br>Hot Compress, Tobradex Drops, Tobradex Ointment | Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment<br>* 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.<br>* Other names: Tobramycin/dexamethasone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Resolution | Defined as number of patients with chalazion size regression of 100% | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |