NCT05110001 — drugset

Summary

Rose Bengal Electromagnetic Activation with Green light for Infection Reduction (REAGIR ) is an international, randomized, doubled masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT). Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with either smear or culture positive fungal or acanthamoeba keratitis or smear and culture negative corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups: Group 4, Sham RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT Group 5, RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT.

Timeline

Start: 2022-08-03
Primary completion: 2024-12-14
Completion: 2025-06-30

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rose bengal disodium	Unknown	0.1 %	Topical
Background	Chlorhexidine gluconate	Other / unclassified	0.02 %	Topical
Background	Moxifloxacin Ophthalmic	Unknown	0.5 %	Topical
Background	Natamycin	Small molecule	5 %	Topical

Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction

Summary

Timeline

Publications

Drugs

Indications