Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial
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Date
2020
Journal Title
Journal ISSN
Volume Title
Publisher
BMJ open
Abstract
Fungal infections of the cornea, fungal
keratitis (FK), are challenging to treat. Current topical
antifungals are not always effective and are often
unavailable, particularly in low-income
and middle-income
countries where most cases occur. Topical natamycin 5%
is usually first-line
treatment, however, even when treated
intensively, infections may progress to perforation of the
eye in around a quarter of cases. Alternative antifungal
medications are needed to treat this blinding disease.
Chlorhexidine is an antiseptic agent with antibacterial
and antifungal properties. Previous pilot studies suggest
that topical chlorhexidine 0.2% compares favourably with
topical natamycin. Full-scale
randomised controlled trials
(RCTs) of topical chlorhexidine 0.2% are warranted to
answer this question definitively.
Methods and analysis We will test the hypothesis
that topical chlorhexidine 0.2% is non-inferior
to topical
natamycin 5% in a two-arm,
single-masked
RCT.
Participants are adults with FK presenting to a tertiary
ophthalmic hospital in Nepal. Baseline assessment
includes history, examination, photography, in vivo
confocal microscopy and cornea scrapes for microbiology.
Participants will be randomised to alternative topical
antifungal treatments (topical chlorhexidine 0.2% and
topical natamycin 5%; 1:1 ratio, 2–6 random block size).
Patients are reviewed at day 2, day 7 (with reculture), day
14, day 21, month 2 and month 3. The primary outcome
is the best spectacle corrected visual acuity (BSCVA) at
3 months. Primary analysis (intention to treat) will be by
linear regression, with treatment arm and baseline BSCVA
prespecified covariates. Secondary outcomes include
epithelial healing time, scar/infiltrate size, ulcer depth,
hypopyon size, perforation and/or therapeutic penetrating
keratoplasty (corneal transplant), positive reculture rate
(day 7) and quality of life (EuroQol-5 dimensions, WHO/
PBD-VF20,
WHOQOL-BREF).
Ethics and dissemination The Nepal Health Research
Council, the Nepal Department of Drug Administration
and the London School of Hygiene and Tropical Medicine
ethics committee have approved the trial. The results
Description
Keywords
Topical chlorhexidine, Topical natamycin, Fungal keratitis
Citation
Hoffman JJ, Yadav R, Das Sanyam S, et al. Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial. BMJ Open 2020;10:e038066. doi:10.1136/ bmjopen-2020-038066