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Chalazion Conservative Treatment Trial

NCT01230593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-06-12

Study results available
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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

Interventions

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.

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

Hot Compresses

Hot compresses 3x/day to eyelids

Sponsors & Collaborators

Principal Investigators

  • Albert Y Wu, M.D., Ph.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230593 on ClinicalTrials.gov