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Chalazion Treatment Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01230593
First received: October 27, 2010
Last updated: October 28, 2010
Last verified: October 2010
History of Changes
  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. This leads to a typically pain, 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 test the efficacy of any of these treatments. We wish to determine the most effective medical treatment for chalazia.


Condition Intervention
Eyelid Chalazion
 Drug: Tobrex Drops and Ointment
Drug: Tobradex Drops and Ointment
Drug: Warm Compresses

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Chalazion Treatment Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Chalazion Size [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change of size of eyelid chalazion in mm.


Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eyelid treatment
Patients not given drops or ointment will be shown how to apply warm compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain.
 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.
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.
Drug: Warm Compresses
Warm Compresses TID to eyelids

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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 lashed) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230593

Contacts
Contact: Albert Wu, M.D., Ph.D. 416-962-5005 albertyapowu@gmail.com

Locations
Canada, Ontario
St. Joseph's Hospital Eye Clinic Recruiting
Stoney Creek, Ontario, Canada, L8G 5E4
Principal Investigator: John T Harvey, M.D.            
Sponsors and Collaborators
McMaster University
  More Information

No publications provided

Responsible Party: John Harvey, M.D., Professor, Division of Ophthalmology, Department of Surgery, McMaster University
ClinicalTrials.gov Identifier: NCT01230593     History of Changes
Other Study ID Numbers: 10-469
Study First Received: October 27, 2010
Last Updated: October 28, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Chalazion
Cysts
Neoplasms
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013