Chlorhexidine 0.2% vs natamycin 5% for the treatment of fungal corneal infections

Conditions

Fungal keratitis Eye Diseases

Hoffman JJ, Yadav R, Sanyam SD, Chaudhary P, Roshan A, Singh SK, Singh SK, Mishra SK, Arunga S, Hu VH, Macleod D, Leck A, Burton MJ.

2021-12-0915 citations

10.1016/j.ophtha.2021.12.004

Topical chlorhexidine 0.2% versus topical natamycin 5% for fungal keratitis in Nepal: rationale and design of a randomised controlled non-inferiority trial

Jeremy Hoffman, Reena Yadav, Sandip Das Sanyam, Pankaj Chaudhary, Abhishek Roshan et al. (13 authors)

BMJ Open2020-09-0120 citations

10.1136/bmjopen-2020-038066

Interventions

Participants will be randomised to either topical chlorhexidine 0.2% or topical natamycin 5%. The treatment will be given hourly for one week, then two-hourly for a further two weeks. Ongoing treatmen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Acute microbial keratinitis characterised by:? 1.1 Corneal epithelial ulceration >1mm diameter ? 1.2 Corneal stromal infiltrate? 1.3 Acute inflammation: e.g. 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)

Exclusion criteria

Exclusion criteria: 1. Unwilling to participate in trial or attend follow-up ? 2. Aged less than 18 years 3. Pregnancy: self-reported, or by urine hCG pregnancy test if uncertain. ? 4. Breast feeding: self-reported ? 5. Prior topical anti-fungal treatment 6. No light perception in the affected eye 7. Fellow eye visual acuity <6/60 ? 8. Acanthamoebic infection visualised by smear microscopy or IVCM 9. Clinical evidence of herpetic keratitis 10. Known allergy to study medication (including preservatives) 11. Previous penetrating keratoplasty in the affected eye 12. Bilateral corneal ulcers 13. Very severe ulcers warranting immediate evisceration or conjunctival flap 14. Fungal Endophthalmitis ?

Design outcomes

Primary

Measure	Time frame
Best Spectacle Corrected Visual Acuity (BSCVA) at 3 months by a trial certified optometrist	—

Secondary

Measure	Time frame
1. Time to full epithelial healing (slit lamp examination by ophthalmologist). 2. Pin-hole visual acuity in logMAR at 3 months, trial-certified optometrist 3. Hard Contact Lens-corrected Visual Acuity measured in logMAR at 3 months 4. Scar/infiltrate size at 1 week, 3 weeks and 3 months (slit lamp examination by ophthalmologist). 5. Ulcer depth at 1 week and 3 weeks (slit lamp examination by ophthalmologist). 6. Hypopyon height at 1 and 3 weeks, (slit lamp examination by ophthalmologists). 7. Perforation and/or TPK by three months (slit lamp examination by ophthalmologist). 8. Positive culture rate at 1 week 9. Ocular adverse effects at each follow up visit (Day 2, Day 7, Day 14, 3 weeks, 2 months, 3 months), slit lamp examination by ophthalmologists. 10. Quality of life (QoL) assessed using: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF (comparison between baseline and QoL measures at 3 months) 11. Cost-effectiveness analysis, using EQ-5D data form 3 months and direct cost data. 12. Drug adherence at each follow up visit (Day 2, Day 7, Day 14, 3 weeks, 2 months, 3 months) whilst the patient is using study medications.	—

Measure

Time frame

1. Time to full epithelial healing (slit lamp examination by ophthalmologist). 2. Pin-hole visual acuity in logMAR at 3 months, trial-certified optometrist 3. Hard Contact Lens-corrected Visual Acuity measured in logMAR at 3 months 4. Scar/infiltrate size at 1 week, 3 weeks and 3 months (slit lamp examination by ophthalmologist). 5. Ulcer depth at 1 week and 3 weeks (slit lamp examination by ophthalmologist). 6. Hypopyon height at 1 and 3 weeks, (slit lamp examination by ophthalmologists). 7. Perforation and/or TPK by three months (slit lamp examination by ophthalmologist). 8. Positive culture rate at 1 week 9. Ocular adverse effects at each follow up visit (Day 2, Day 7, Day 14, 3 weeks, 2 months, 3 months), slit lamp examination by ophthalmologists. 10. Quality of life (QoL) assessed using: EQ-5D, WHO/PBD-VF20, WHOQOL-BREF (comparison between baseline and QoL measures at 3 months) 11. Cost-effectiveness analysis, using EQ-5D data form 3 months and direct cost data. 12. Drug adherence at each follow up visit (Day 2, Day 7, Day 14, 3 weeks, 2 months, 3 months) whilst the patient is using study medications.

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Countries

Nepal

Contacts

Public ContactJeremy Hoffman

jeremy.hoffman@lshtm.ac.uk+442076368636

Outcome results

None listed