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NOT YET RECRUITING
NCT07743489
PHASE3

RB-PDT for Fusarium Keratitis: The LUMIERE Study

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

This is a multicenter trial with recruitment planned at ophthalmology clinics specializing in corneal diseases in India, Brazil, and at Stanford University and Bascom Palmer Eye Institute in the United States. Fusarium keratitis is common in tropical and subtropical regions like Florida, India and Brazil, which will facilitate access to the required number of participants. The study aims to recruit a total of 434 participants (217 per group).

Official title: Light for Ulcer Management by Infection Elimination and Resistance Enhancement (LUMIERE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

434

Start Date

2027-01

Completion Date

2030-01

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

DRUG

Rose Bengal Photodynamic Therapy

RB-PDT/sham RB-PDT will occur within 5 days of initial smear/culture. For Group 1, Rose Bengal (0.1% RB in 0.9% sodium chloride) will be applied in 3-minute intervals to the de-epithelialized cornea for 30 minutes followed by irradiation with a 6mW/cm2 custom-made green LED source for 15 minutes (5.4J/cm2). A second RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.

DRUG

Sham RB-PDT

Participants in Group 2 will undergo a sham procedure using topical balanced salt solution and pen light covered with a green filter. Study participants will undergo repeat scraping and culture of the corneal ulcer 30 minutes after the assigned RB-PDT procedure. A second sham RB-PDT procedure and repeat smear/culture will occur one week after the first procedure, following the same protocol.

Locations (4)

Stanford University

Palo Alto, California, United States

University of Miami - Bascom Palmer Eye Institute

Miami, Florida, United States

Federal University of São Paulo

São Paulo, Brazil

Aravind Eye Care System

Madurai, Tamil Nadu, India