Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

NCT06658002 · tracked via the Priya Life Science India tracker

Sponsor

University of California, San Francisco

Phase

Phase 3

Started

2025-09-01

Last updated

2026-06-05

Condition(s) studied

Fungal KeratitisCorneal Ulcer

Investigational drug(s) / intervention(s)

Cyclosporine APlacebo Comparator: Placebo

Cyclosporine A: 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: Placebo: 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 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Best Spectacle Corrected Visual Acuity (BSCVA) — 12 weeks

Trial sites (2)

Facility	City	Region	Status
University of California, San Farncisco	San Francisco	California	Not Yet Recruiting
Aravind Eye Institute	Pondicherry	Tamil Nadu	Recruiting

More University of California, San Francisco trials in India

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II Active, not recruiting

Group-based Life Skills and Health Empowerment for Married Women to Avoid Unintended Pregnancies in India Active, not recruiting

Rapid Research in Diagnostics Development for TB Network Recruiting

mHealth India Postnatal Health Intervention Effectiveness Recruiting

Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06658002 on ClinicalTrials.gov ↗ ← All trials in India