None listed
Conditions
Brief summary
Bacterial keratitis (bacterial infection of the cornea) can cause permanent scarring of the cornea resulting in visual loss possibly requiring corneal transplant. Scarring is caused in large part by the infection but also by the body’s immune/inflammatory response to infection with subsequent opacification of the cornea. It is thought that suppressing the immune/inflammatory response through the use of topical corticosteroid will reduce the incidence of permanent corneal scarring and minimise visual loss. The proposed study will be randomised, placebo controlled, and double-masked. All participants will remain on topical antibiotics throughout the study; in addition, one group will receive corticosteroid eye-drops, the other an identical placebo eye-drop. Neither the patients nor the investigators will know which treatment is being used until results have been analysed.
Interventions
Topical corticosteroid prednisolone acetate 1.0% (one eyedrop four times daily for three weeks).
Intervention and control study arms will also receive topical ciprofloxacin 0.3% (antibiotic) one drop hourly during waking hours for the first 48 hours, then 2 hourly during waking hours until re-epithelialisation, then four times daily whilst using the study drug (three weeks).
Study medication will be introduced on day 4 of treatment with at least two days of progressive corneal improvement and
Topical corticosteroid prednisolone acetate 1.0% (one eyedrop four times daily for three weeks). Intervention and control study arms will also receive topical ciprofloxacin 0.3% (antibiotic) one drop hourly during waking hours for the first 48 hours, then 2 hourly during waking hours until re-epithelialisation, then four times daily whilst using the study drug (three weeks). Study medication will be introduced on day 4 of treatment with at least two days of progressive corneal improvement and will be administered four times a day for three weeks until a study endpoint has occurred (e.g. healing, worsening). If participants have a bacterial strain resistant to ciprofloxacin, as per usual management, treatment with another suitable topical antibiotic will be instigated.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of culture postivie bacterial keratitis, corneal defect less than or equal to 1.5mm and not within 1.0mm of the limbus, aged 16 or over, topical antibiotic given for at least three days with signs of clinical improvement.
Exclusion criteria
Corneal perforation or impending perforation, descemetocele or endophthalmitis, evidence of herptic keratitis, fungal, or acanthambeoba infection by exam or history, pre-existing corneal scar, use of topical steriod in affected eye or systemic corticosteriod during course of present infection, aged under 16 years, bilateral corneal infections, previous penetrating corneal transplant, pregnancy, best corrected vision worse than 6/60 in fellow eye, allergy to study drugs, uncontrolled systemic disease, concurrent ocular infections and patients requiring treatment with subconjuctival injection.
Outcome results
None listed