Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06658002
Phase
PHASE3
Status
Recruiting
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Conditions

  • Corneal Ulcer
  • Fungal Keratitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclosporine A — DRUG
    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.
  • Placebo Comparator: Placebo — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cyclosporine A (CsA) 0.1%
    After one week of hourly natamycin eye drops the participants in this arm will use this drop four times a day for one month then twice a day for one month.
  • Experimental: Cyclosporine A (CsA) 2%
    After one week of hourly natamycin eye drops the participants in this arm will use this drop four times a day for one month then twice a day for one month.
  • Placebo Comparator: Placebo
    After one week of hourly natamycin eye drops the participants in this arm will use this drop four times a day for one month then twice a day for one month.

Primary Outcome Measure

Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FarnciscoSan FranciscoCalifornia94143
Gerami D Seitzman, MD
[email protected]
415-476-1442
Brianna K Colado, BA
[email protected]
5593492629

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By research site
University of California, San Farncisco· San Francisco, CA

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