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Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

NCT06658002 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Fungal Keratitis
  • Corneal Ulcer

Interventions

DRUG

Cyclosporine 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.

OTHER

Placebo 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.

Sponsors & Collaborators

Principal Investigators

  • Gerami D Seitzman, MD · UCSF Proctor Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-09-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States
  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06658002 on ClinicalTrials.gov