Comparison of antibiotic-only and antibiotic-steroid combination treatment in corneal ulcer patients: a double-blinded, randomised clinical trial

ISRCTN	ISRCTN71482124
DOI	https://doi.org/10.1186/ISRCTN71482124
Protocol serial number	N/A
Sponsor	Physicians' Services Incorporated Foundation (Canada)
Funder	Physicians' Services Inc (Canada)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr William Hodge
Scientific

Ottawa Hospital - General Campus
The University of Ottawa Eye Institute
501 Smyth Road
Ottawa, Ontario
K1H 8L6
Canada

Phone	+1 613 737 8218
Email	whodge@ottawahospital.on.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Corneal ulcers
Intervention	Antibiotic-only or Antibiotic-steroid combination treatment
Intervention type	Other
Primary outcome measure(s)	Residual ulcer size compared to baseline
Key secondary outcome measure(s)	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
Completion date	14/09/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	122
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	15/09/2005
Date of final enrolment	14/09/2007

Ottawa Hospital - General Campus

Ottawa, Ontario
K1H 8L6
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan