Table 5

Registration data and protocol summary

Data categoryInformation
Primary registry and trial identifying noISRCTN Registry; ISRCTN14332621
Date of registration in primary registry15 May 2019
Secondary identifying numbers 
Source(s) of monetary or material supportWellcome Trust
Primary sponsorLondon School of Hygiene and Tropical Medicine
Secondary sponsor(s) 
Contact for queriesJeremy Hoffman FRCOphth (Jeremy.hoffman@lshtm.ac.uk)
TitleChlorhexidine 0.2% vs Natamycin 5% for the treatment of fungal corneal infections
Countries of recruitmentNepal
Health condition(s) or problem(s) studiedFungal keratitis
Intervention(s)Participants will be randomised to either topical chlorhexidine 0.2% or topical natamycin 5%
Key eligibility criteria1. Acute MK characterised by:

  • Corneal epithelial ulceration >1 mm diameter

  • Corneal stromal infiltrate

  • Acute inflammation: for example, conjunctival injection, anterior chamber inflammatory cells, hypopyon

2. Filamentous fungal hyphae visualised on smear microscopy and/or in vivo confocal microscopy
3. Agree to be randomised to either treatment arm and able to give informed consent
4. Agree to be followed up at 2 days, 1 week, 2 weeks, 3 weeks, 2 months and 3 months
5. Adults (18 years and older)
Study typeRandomised controlled trial
Date of first enrolment1 June 2019
Target sample size500
Recruitment statusRecruiting
Primary outcome(s)Best Spectacle Corrected Visual Acuity at 3 months by a trial certified optometrist
Key secondary outcomes1. Time to full epithelial healing (slit lamp examination by ophthalmic clinician)
2. Pin-hole visual acuity in logMAR at 3 months, trial-certified optometrist
3. Scar/infiltrate size at 1 week, 3 weeks and 3 months (slit-lamp examination by ophthalmic clinician)
4. Ulcer depth at 1 week and 3 weeks (slit-lamp examination by ophthalmic clinician).
5. Hypopyon height at 1 and 3 weeks, (slit-lamp examination by ophthalmic clinician).
6. Perforation and/or TPK by 3 months (slit-lamp examination by ophthalmic clinician).
7. Positive culture rate at 1 week
8. Ocular adverse effects at each follow-up visit (day 2, day 7, day 14, 3 weeks, 2 months, 3 months), slit-lamp examination by ophthalmic clinician
9. Quality of life (QoL) assessed using: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF (comparison between baseline and QoL measures at 3 months)
10. Cost-effectiveness analysis, using EQ-5D data from 3 months and direct cost data
11. Drug adherence at each follow-up visit (day 2, day 7, day 14, 3 weeks, 2 months, 3 months) while the patient is using study medications

  • EQ-5D, EuroQol-5 Dimension; LMIC, low-income and middle-income countries; MK, microbial keratitis; TPK, therapeutic penetrating keratoplasty.