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NCT Number: NCT06658002

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

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.

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Key information

Conditions

Fungal Keratitis Corneal Diseases Corneal Ulcer Eye Diseases Eye Infections Infections Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aravind Eye Institute, Pondicherry, Tamil Nadu, India

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About this study

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 beneficial adjuvant to natamycin in the treatment of mild to moderate fungal keratitis.
  • to determine if adjunctive 2% cyclosporine A demonstrates greater efficacy than 0.1% cyclosporine A in the treatment of fungal keratitis.
  • to determine which ulcer characteristics, predict the most benefit from the addition of early topical cyclosporine.

In this study the investigators will partner with their cornea colleagues at the Aravind Eye Hospital. This is because the incidence of fungal corneal ulcers is among the highest in the world in this location.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Subjects taking cyclosporine at any concentration on presentation.
  • Acuity worse than 20/200 = 6/60 = +1.0 Log MAR in unaffected eye.
  • Pregnant women.
  • Penetrating Keratoplasty.
  • Presents with a 0-7 day history of topical steroid.

Treatment and study plan

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.

Primary outcomes

  1. Best Spectacle Corrected Visual Acuity (BSCVA)

    Time frame: 12 weeks

Secondary outcomes

  1. Corneal Scar Size

    Time frame: 12 weeks

  2. Corneal Perforation Rate

    Time frame: 12 weeks

  3. Corneal Ulcer Re-epithelialization

    Time frame: 12 weeks

  4. Microbiologic Cure Rate

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Gerami D Seitzman, MD

CONTACT

[email protected]

4154761442

Thomas Lietman, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Aravind Eye Care System
  • Aravind Eye Hospitals, India

Registry information

Acronym: FANCY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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