NCT06658002 Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
| NCT ID | NCT06658002 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, San Francisco |
| Condition | Fungal Keratitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2025-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Gerami D Seitzman, MD
PRINCIPAL INVESTIGATOR
UCSF Proctor Foundation
Frequently Asked Questions
Who can join the NCT06658002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fungal Keratitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06658002 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT06658002 currently recruiting?
Yes, NCT06658002 is actively recruiting participants. Contact the research team at gerami.seitzman@ucsf.edu for enrollment information.
Where is the NCT06658002 trial being conducted?
This trial is being conducted at San Francisco, United States, Pondicherry, India.
Who is sponsoring the NCT06658002 clinical trial?
NCT06658002 is sponsored by University of California, San Francisco. The principal investigator is Gerami D Seitzman, MD at UCSF Proctor Foundation. The trial plans to enroll 150 participants.