Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
University of California, San Francisco
Summary
The goal of this clinical trial is to learn if adjunctive topical Cyclosporine A eye drops combined with standard of care topical Natamycin treatment improves vision outcomes in patients with fungal keratitis.
Description
This is a randomized, masked, clinical trial of patients with documented fungal infections of the cornea. In this trial participants are treated with (standard of care) topical natamycin for a minimum of 48 hours and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, or CsA 2%, or placebo for 4 weeks. Natamycin will be continued until the corneal ulcer has resolved. The primary outcome of this pilot trial is best corrected visual acuity (BCVA) at 3 months. The specific aims of this trial are to: * to determine if early use of topical cyclosporine A is a bene…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Inclusion is based on presenting acuity, not ulcer size. * Inclusion of 20/40 = 6/12 = 0.3 Log MAR and 20/400 = 3/60 = +1.3 Log MAR. * Smear or culture positive for fungal keratitis, any length. * Age 18 years. * Willing to participate in study. Exclusion Criteria: * Co-infection with bacterial or viral keratitis. * Corneal perforation. * Requiring therapeutic keratoplasty for fungal keratitis. * Unwilling or unable to follow up (e.g., living too far from hospital). * Presenting acuity better than 20/40 = 6/12 = 0.3 Log MAR or worse than 20/400 = 3/60 = +1.3 Log MAR. *…
Interventions
- DrugCyclosporine A
Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, 2% or placebo for 4 weeks. Natamycin is continued until the ulcer has healed.
- OtherPlacebo Comparator: Placebo
Participants with smear or culture proven fungal keratitis are treated for a minimum of 48 hours with topical natamycin and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, 2% or placebo for 4 weeks. Natamycin is continued until the ulcer has healed.
Locations (2)
- University of California, San FarnciscoSan Francisco, California
- Aravind Eye InstitutePondicherry, Tamil Nadu