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
Secondary identifying numbers	N/A

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	Residual ulcer size compared to baseline
Secondary outcome measures	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
Overall study start date	15/09/2005
Completion date	14/09/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Physicians' Services Incorporated Foundation (Canada)
Charity

1006-5160 Yonge Street
North York, Ontario
M2N 6L9
Canada

Charity

Physicians' Services Inc (Canada)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan