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Chalazion Conservative Treatment Trial

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ClinicalTrials.gov Identifier: NCT01230593
Recruitment Status : Completed
First Posted : October 29, 2010
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Edward-Elmhurst Health System
Information provided by (Responsible Party):
Albert Wu, McMaster University

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.

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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hot Compress
"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.
Other Names:
  • Aktob
  • Tobralcon
  • Tobrasol
  • Tobramycin

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




Primary Outcome Measures :
  1. Number of Participants With Complete Resolution [ Time Frame: 4-6 weeks ]
    Defined as number of patients with chalazion size regression of 100%


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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
Canada, Ontario
St. Joseph's Hospital Eye Clinic
Stoney Creek, Ontario, Canada, L8G 5E4
Sponsors and Collaborators
McMaster University
Icahn School of Medicine at Mount Sinai
Edward-Elmhurst Health System
Investigators
Principal Investigator: Albert Y Wu, M.D., Ph.D. Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albert Wu, M.D. Ph.D., McMaster University
ClinicalTrials.gov Identifier: NCT01230593     History of Changes
Other Study ID Numbers: 10-469
First Posted: October 29, 2010    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Tobramycin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents