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RecruitingNCT06658002FANCYUpdated Jun 5, 2026

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

A Phase 3 interventional study of Cyclosporine A and Placebo Comparator: Placebo in Fungal Keratitis and Corneal Ulcer, sponsored by University of California, San Francisco. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by University of California, San Francisco · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed 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 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.

02

Conditions studied

  • Fungal Keratitis
  • Corneal Ulcer

Browse trials for

Keywords

  • Corneal Ulcer
  • Cyclosporine A
  • Fungal Keratitis
  • Fungal Corneal Ulcer
03

In context

Corneal Ulcer

63 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 45 interventional studies indexed under Corneal Ulcer.

Browse Corneal Ulcer studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study 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.

    Drug: Cyclosporine A

  • 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.

    Drug: Cyclosporine A

  • 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.

    Other: Placebo Comparator: Placebo

Interventions

  • 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.

06

What researchers measure

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

07

Study locations

1 of 2 sites recruiting
  • University of California, San Farncisco
    San Francisco, California 94143, United States
    Not yet recruiting
  • Aravind Eye Institute
    Pondicherry, Tamil Nadu 605 007, India
    Recruiting
08

References and documents

Publications

  • Chatterjee S, Agrawal D. Use of Topical Cyclosporine 0.1% in Therapeutic Penetrating Keratoplasty for Fungal Keratitis. Cornea. 2022 Sep 1;41(9):1116-1121. doi: 10.1097/ICO.0000000000002827. Epub 2021 Sep 3. PubMed 34483271 ↗
  • Kauss Hornecker M, Charles Weber S, Brandely Piat ML, Darrodes M, Jomaa K, Chast F. [Cyclosporine eye drops: A 4-year retrospective study (2009-2013)]. J Fr Ophtalmol. 2015 Oct;38(8):700-8. doi: 10.1016/j.jfo.2015.02.008. Epub 2015 Sep 11. French. PubMed 26371985 ↗
  • Bell NP, Karp CL, Alfonso EC, Schiffman J, Miller D. Effects of methylprednisolone and cyclosporine A on fungal growth in vitro. Cornea. 1999 May;18(3):306-13. doi: 10.1097/00003226-199905000-00012. PubMed 10336034 ↗
  • Perry HD, Doshi SJ, Donnenfeld ED, Bai GS. Topical cyclosporin A in the management of therapeutic keratoplasty for mycotic keratitis. Cornea. 2002 Mar;21(2):161-3. doi: 10.1097/00003226-200203000-00006. PubMed 11862086 ↗
  • Cordeiro RA, Macedo RB, Teixeira CEC, Marques FJF, Bandeira TJPG, Moreira JLB, Brilhante RSN, Rocha MFG, Sidrim JJC. The calcineurin inhibitor cyclosporin A exhibits synergism with antifungals against Candida parapsilosis species complex. J Med Microbiol. 2014 Jul;63(Pt 7):936-944. doi: 10.1099/jmm.0.073478-0. Epub 2014 Apr 10. PubMed 24722799 ↗
  • Survase SA, Kagliwal LD, Annapure US, Singhal RS. Cyclosporin A--a review on fermentative production, downstream processing and pharmacological applications. Biotechnol Adv. 2011 Jul-Aug;29(4):418-35. doi: 10.1016/j.biotechadv.2011.03.004. Epub 2011 Apr 5. PubMed 21447377 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06658002
Collaborators
Aravind Eye Hospitals, India, Aravind Eye Care System
Responsible party
Sponsor
First posted
Oct 26, 2024
Start date
Sep 1, 2025
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Jun 5, 2026

Study contacts

Gerami D Seitzman, MD
Contact
gerami.seitzman@ucsf.edu
4154761442
Thomas Lietman, MD
Contact
tom.lietman@ucsf.edu
Gerami D Seitzman, MD
principal investigator · UCSF Proctor Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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