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ISRCTN
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ISRCTN71482124
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ClinicalTrials.gov identifier
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Public title
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Comparison of antibiotic-only and antibiotic-steroid combination treatment in corneal ulcer patients: a double-blinded, randomised clinical trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Null: There is no difference in residual ulcer size whether a corneal ulcer patient was treated with antibiotic alone or antibiotic with steroid.
Alternative: There is a significant difference in residual ulcers size between corneal ulcer patients treated with antibiotic alone and with antibiotic with steroid.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Corneal ulcers
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Participants - inclusion criteria
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1. Bacterial corneal ulcer, defined as corneal epithelial defect and stromal inflammation of presumed bacterial origin,that is culture confirmed or gram stain positive
2. Involvement of only one eye
3. Over the age of 12 years
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Participants - exclusion criteria
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1. Fungal, viral or amoebic keratitis
2. Known sensitivity or allergy to trial drugs
3. Perforated ulcer
4. Involvement of only functional eye, best corrected visual acuity worse than 20/200 in the uninfected eye
5. Use of topical or systemic steroids concurrently or within the past 2 months
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Anticipated start date
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15/09/2005
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Anticipated end date
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14/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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122
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Interventions
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Antibiotic-only or Antibiotic-steroid combination treatment
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Primary outcome measure(s)
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Residual ulcer size compared to baseline
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Secondary outcome measure(s)
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1. Time to healing (days)
2. Rate of cure or treatment failure
3. Visual acuity
4. Quality of life
5. Physician Scoring of Ocular symptoms and signs
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Sources of funding
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Physicians' Services Inc (Canada)
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Trial website
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Publications
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Contact name
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Dr
William
Hodge
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Address
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Ottawa Hospital - General Campus
The University of Ottawa Eye Institute
501 Smyth Road
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City/town
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Ottawa, Ontario
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Zip/Postcode
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K1H 8L6
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Country
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Canada
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Tel
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+1 613 737 8218
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Fax
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+1 613 739 6139
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Email
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whodge@ottawahospital.on.ca
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Sponsor
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Physicians' Services Incorporated Foundation (Canada)
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Address
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1006-5160 Yonge Street
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City/town
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North York, Ontario
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Zip/Postcode
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M2N 6L9
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Country
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Canada
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Tel
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+1 416 226 6323
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Fax
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+1 416 226 6080
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Email
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psif@psifoundation.org
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Date applied
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24/08/2005
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Last edited
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15/09/2009
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Date ISRCTN assigned
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21/10/2005
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