Chalazion Conservative Treatment Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01230593|
Recruitment Status : Completed
First Posted : October 29, 2010
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
|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: Hot Compress plus Tobramycin Drops and Ointment Drug: Hot compress plus Tobramycin/Dexamethasone 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
Other: Hot Compresses
Hot compresses 3x/day to eyelids
Active Comparator: Tobrex
"Hot Compress", "Tobrex Drops", "Tobrex Ointment"
Drug: Hot 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.
Active Comparator: Tobradex
"Hot Compress", "Tobradex Drops", "Tobradex Ointment"
Drug: Hot 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.
Other Name: Tobramycin/dexamethasone
- Number of Participants With Complete Resolution [ Time Frame: 4-6 weeks ]Defined as number of patients with chalazion size regression of 100%
- Chalazion Size Difference Post-Treatment [ Time Frame: baseline and 4-6 weeks ]Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
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|