Chalazion Conservative Treatment Trial
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|ClinicalTrials.gov Identifier: NCT01230593|
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chalazion Unspecified Eye, Unspecified Eyelid Chalazion Left Eye, Unspecified Eyelid Chalazion Right Eye, Unspecified Eyelid Chalazion Both Eyes||Drug: Tobrex Drops and Ointment Drug: Tobradex Drops and Ointment Other: Hot Compresses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: 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.
Other: Hot Compresses
Hot compresses 3x/day to eyelids
Active Comparator: Tobrex Drops and Ointment
Patients in the Tobrex arm will be prescribed Tobrex drops 3x/day and ointment to be applied before bedtime.
Drug: Tobrex Drops and Ointment
Tobrex drops will be given to the affected eye 3x/day, and Tobrex ointment will be given at night before bed.
Active Comparator: Tobradex Drops and Ointment
Patients in the Tobradex arm will be prescribed Tobradex drops 3x/day and ointment to be applied before bedtime.
Drug: Tobradex Drops and Ointment
Tobradex drops will be given to the affected eye 3x/day, and Tobradex ointment will be given at night before bed.
Other Name: Tobramycin/dexamethasone
- Complete resolution [ Time Frame: 4-6 weeks ]Defined as chalazion size regression of 100%
- Chalazion Size Difference Post-Treatment [ Time Frame: 4-6 weeks ]Change of size of eyelid chalazion in mm
- Percent chalazion size improvement [ Time Frame: 4-6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230593
|United States, New York|
|Elmhurst Hospital Center|
|Elmhurst, New York, United States, 11373|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|St. Joseph's Hospital Eye Clinic|
|Stoney Creek, Ontario, Canada, L8G 5E4|
|Principal Investigator:||Albert Y Wu, M.D., Ph.D.||Icahn School of Medicine at Mount Sinai|