Natamycin plus cyclosporine eye drops for fungal corneal ulcers
Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
This test tries adding cyclosporine eye drops to standard natamycin drops to see if people with fungal corneal ulcers get better vision.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06658002 on ClinicalTrials.gov |
What this trial studies
This randomized, masked trial enrolls adults with smear- or culture-confirmed fungal keratitis who start standard topical natamycin for at least 48 hours. Participants are randomized 1:1:1 to receive topical cyclosporine A 0.1%, cyclosporine A 2%, or placebo for four weeks while continuing natamycin until the ulcer resolves. The primary outcome is best corrected visual acuity at three months, and investigators will analyze which ulcer features predict the most benefit. The trial is conducted at UCSF in partnership with Aravind Eye Hospital in India to enroll patients where fungal ulcers are common.
Who should consider this trial
Good fit: Adults (≥18) with smear- or culture-positive fungal keratitis and presenting visual acuity between 20/40 and 20/400 who can attend follow-up visits are ideal candidates.
Not a fit: Patients with corneal perforation, mixed bacterial or viral co-infection, those already taking cyclosporine, pregnant women, or those needing immediate keratoplasty are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, adding cyclosporine could improve three-month vision outcomes and reduce scarring from fungal corneal ulcers.
How similar studies have performed: There is limited prior evidence from small studies and case reports suggesting topical cyclosporine might help, but no definitive large trials have proven benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Francisco, California and 1 other locations
- University of California, San Farncisco — San Francisco, California, United States (Not_yet_recruiting)
- Aravind Eye Institute — Pondicherry, Tamil Nadu, India (Recruiting)
Study contacts
- Principal investigator: Gerami D Seitzman, MD — UCSF Proctor Foundation
- Study coordinator: Gerami D Seitzman, MD
- Email: gerami.seitzman@ucsf.edu
- Phone: 4154761442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.