Chalazion Conservative Treatment Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hot Compress

"Hot Compress"

Group Type ACTIVE_COMPARATOR

Hot Compresses

Intervention Type OTHER

Hot compresses 3x/day to eyelids

Tobrex

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

Group Type ACTIVE_COMPARATOR

Hot Compress plus Tobramycin Drops and Ointment

Intervention Type 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.

Tobradex

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

Group Type ACTIVE_COMPARATOR

Hot compress plus Tobramycin/Dexamethasone Drops and Ointment

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Hot Compresses

Hot compresses 3x/day to eyelids

Intervention Type OTHER

Other Intervention Names

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Aktob Tobralcon Tobrasol Tobramycin Tobramycin/dexamethasone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No