Chalazion Conservative Treatment Trial

NCT01230593 | Completed Results

• 1 other identifier: 10-469
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 3

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.

Conditions

Chalazion Unspecified Eye, Unspecified Eyelid; Chalazion Left Eye, Unspecified Eyelid; Chalazion Right Eye, Unspecified Eyelid; Chalazion Both Eyes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Resolution

  Defined as number of patients with chalazion size regression of 100%

  4-6 weeks

Secondary Outcomes (1)

• Chalazion Size Difference Post-Treatment

  baseline and 4-6 weeks

Study Arms (3)

Hot Compress

ACTIVE COMPARATOR

"Hot Compress"

Other: Hot Compresses

Tobrex

ACTIVE COMPARATOR

"Hot Compress", "Tobrex Drops", "Tobrex Ointment"

Drug: Hot Compress plus Tobramycin Drops and Ointment

Tobradex

ACTIVE COMPARATOR

"Hot Compress", "Tobradex Drops", "Tobradex Ointment"

Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment

Interventions

Hot Compress plus Tobramycin Drops and Ointment DRUG

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.

Also known as: Aktob, Tobralcon, Tobrasol, Tobramycin

Tobrex

Hot compress plus Tobramycin/Dexamethasone Drops and Ointment DRUG

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.

Also known as: Tobramycin/dexamethasone

Tobradex

Hot Compresses OTHER

Hot compresses 3x/day to eyelids

Hot Compress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Edward-Elmhurst Health System: collaborator

Study Sites (3)

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

St. Joseph's Hospital Eye Clinic

Stoney Creek, Ontario, L8G 5E4, Canada

Location

Related Publications (1)

• Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16.

  PMID: 29338124 DERIVED

MeSH Terms

Interventions

Ointments; Tobramycin; Tobramycin, Dexamethasone Drug Combination

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Dexamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Combinations

Limitations and Caveats

Large loss to follow-up - only 70% completed follow-up - was a limitation.

Results Point of Contact

• Title: Albert Wu MD PhD
• Organization: Icahn School of Medicine at Mount Sinai

albert.wu@mssm.edu

2125184524

Study Officials

• Albert Y Wu, M.D., Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 12, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-06

Locations

US (2); CA (1)