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

Not Applicable

Completed

• Conditions: Eye Diseases; Fungal keratitis

• Registration Number: ISRCTN14332621
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34896126/ (added 14/12/2021) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32998924/ (added 17/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-15
• Study Completion: 2021-02-08
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 354

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

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 ?

Study & Design

• Study Type: Interventional
• Study Design: Not specified