Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California, San Farncisco
NOT_YET_RECRUITING
San Francisco
Other Locations
India
Aravind Eye Institute
RECRUITING
Pondicherry
Contact Information
Primary
Gerami D Seitzman, MD
gerami.seitzman@ucsf.edu
4154761442
Backup
Thomas Lietman, MD
tom.lietman@ucsf.edu
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 150
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Aravind Eye Care System, Aravind Eye Hospitals, India
Leads: University of California, San Francisco