Fungal KeratitisPhase 3FANCYNCT06658002
Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
A Phase 3 study testing Cyclosporine A in people with Fungal Keratitis and Corneal Ulcer, run by University of California, San Francisco at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Keratitis, Corneal Ulcer
- What is being tested?
- Cyclosporine A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Thomas Lietman, MD contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
University of California, San Farncisco
San Francisco, California, 94143
Gerami D Seitzman, MD, 415-476-1442, gerami.seitzman@ucsf.edu
Brianna K Colado, BA, 5593492629, brianna.colado@ucsf.edu
India1 site, 1 recruiting
- Recruiting
Aravind Eye Institute
Pondicherry, Tamil Nadu, 605 007
Josephine Christy, MD, josephine@aravind.org
Kunal Mandlik, MD
About this study
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.
- Conditions
- Fungal Keratitis, Corneal Ulcer
- Being tested
- Cyclosporine A, Placebo Comparator: Placebo
- Keywords
- Corneal Ulcer, Cyclosporine A, Fungal Keratitis, Fungal Corneal Ulcer
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
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: PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Cyclosporine A (CsA) 0.1% | Experimental | 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. Receives: Drug: Cyclosporine A |
| Cyclosporine A (CsA) 2% | Experimental | 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. Receives: Drug: Cyclosporine A |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Spectacle Corrected Visual Acuity (BSCVA)
Measured: 12 weeks
Secondary outcomes (4)
Corneal Scar Size
Measured: 12 weeks
Corneal Perforation Rate
Measured: 12 weeks
Corneal Ulcer Re-epithelialization
Measured: 12 weeks
Microbiologic Cure Rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fungal KeratitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a randomized controlled trial in which 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% or CsA 2% or placebo for 4 weeks. In cases of bilateral fungal keratitis, if both eyes fit inclusion criteria, the eye with worse acuity will be randomized. The primary outcome is Best Corrected Visual Acuity (BCVA) at 3 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Aravind Eye Hospitals, India, Aravind Eye Care System
- Responsible party
- Sponsor
- Investigators
- Gerami D Seitzman, MD, Principal investigator, UCSF Proctor Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658002
- Sponsor's protocol ID
- 24-41971
- Acronym
- FANCY
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 34483271Kauss 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 26371985Bell 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 10336034Perry 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 11862086Cordeiro 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 24722799Survase 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
- ClinicalTrials.gov ID
- NCT06658002
- Acronym / sponsor ID
- FANCY / 24-41971
- Conditions
- Fungal Keratitis, Corneal Ulcer
- Keywords
- Corneal Ulcer, Cyclosporine A, Fungal Keratitis, Fungal Corneal Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Aravind Eye Hospitals, India, Aravind Eye Care System
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized controlled trial in which 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% or CsA 2% or placebo for 4 weeks. In cases of bilateral fungal keratitis, if both eyes fit inclusion criteria, the eye with worse acuity will be randomized. The primary outcome is Best Corrected Visual Acuity (BCVA) at 3 months.
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A (CsA) 0.1% | Experimental | Drug: Cyclosporine AAfter 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. |
| Cyclosporine A (CsA) 2% | Experimental | Drug: Cyclosporine AAfter 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 | Placebo comparator | Other: Placebo Comparator: PlaceboAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine AParticipants 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. | Drug | Cyclosporine A (CsA) 0.1%, Cyclosporine A (CsA) 2% |
| Placebo Comparator: PlaceboParticipants 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 |
Primary outcome
Best Spectacle Corrected Visual Acuity (BSCVA)
Time frame: 12 weeks
4 secondary outcomes
Corneal Scar Size
Time frame: 12 weeks
Corneal Perforation Rate
Time frame: 12 weeks
Corneal Ulcer Re-epithelialization
Time frame: 12 weeks
Microbiologic Cure Rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 34483271Chatterjee 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.
- Background: PubMed 26371985Kauss 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.
- Background: PubMed 10336034Bell 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.
- Background: PubMed 11862086Perry 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.
- Background: PubMed 24722799Cordeiro 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.
- Background: PubMed 21447377Survase 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Lietman, MD contact
Gerami D Seitzman, MD principal investigator
UCSF Proctor Foundation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyclosporine A in people with Fungal Keratitis and Corneal Ulcer, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerami D Seitzman, MD (4154761442, gerami.seitzman@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Spectacle Corrected Visual Acuity (BSCVA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658002, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.