Chalazion Conservative Treatment Trial

This study has been completed.
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Elmhurst Hospital Center
Information provided by (Responsible Party):
Albert Wu, McMaster University
ClinicalTrials.gov Identifier:
NCT01230593
First received: October 27, 2010
Last updated: February 20, 2016
Last verified: February 2016
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Positive Treatment Impact [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
    Defined as chalazion size regression of at least 10%


Secondary Outcome Measures:
  • Chalazion Size Difference Post-Treatment [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
    Change of size of eyelid chalazion in mm

  • Percent chalazion size improvement [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: November 2010
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Aktob
  • Tobralcon
  • Tobrasol
  • Tobramycin
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Elmhurst Hospital Center
Investigators
Principal Investigator: Albert Y Wu, M.D., Ph.D. Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Albert Wu, M.D. Ph.D., McMaster University
ClinicalTrials.gov Identifier: NCT01230593     History of Changes
Other Study ID Numbers: 10-469 
Study First Received: October 27, 2010
Last Updated: February 20, 2016
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board

Additional relevant MeSH terms:
Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases
Dexamethasone
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
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 29, 2016