Condition category
Eye Diseases
Date applied
24/08/2005
Date assigned
21/10/2005
Last edited
15/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr William Hodge

ORCID ID

Contact details

Ottawa Hospital - General Campus
The University of Ottawa Eye Institute
501 Smyth Road
Ottawa
Ontario
K1H 8L6
Canada
+1 613 737 8218
whodge@ottawahospital.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Corneal ulcers

Intervention

Antibiotic-only or Antibiotic-steroid combination treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/09/2005

Overall trial end date

14/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

122

Participant 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

Recruitment start date

15/09/2005

Recruitment end date

14/09/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Ottawa Hospital - General Campus
Ottawa, Ontario
K1H 8L6
Canada

Sponsor information

Organisation

Physicians' Services Incorporated Foundation (Canada)

Sponsor details

1006-5160 Yonge Street
North York
Ontario
M2N 6L9
Canada
+1 416 226 6323
psif@psifoundation.org

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Physicians' Services Inc (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes