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NCT06658002
Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
Conditions: Fungal Keratitis, Corneal Ulcer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 150
Sponsor: University of California, San Francisco
Location: University of California, San Farncisco San Francisco California
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.
Source: ClinicalTrials.gov (NCT06658002). StuddyBuddy aggregates publicly available trial information.