M. Nagl et al., TOLERANCE OF N-CHLOROTAURINE, AN ENDOGENOUS ANTIMICROBIAL AGENT, IN THE RABBIT AND HUMAN EYE - A PHASE-I CLINICAL-STUDY, Journal of ocular pharmacology and therapeutics, 14(3), 1998, pp. 283-290
N-chlorotaurine (NCT), an essential weak oxidative N-chloro compound p
roduced by stimulated human leukocytes, shows bactericidal, fungicidal
, virucidal and vermicidal efficacy. A double-blind, randomized and pl
acebo controlled study was done to evaluate the tolerance of the aqueo
us NCT solution by application to rabbit and human conjunctiva. In six
rabbits treated with 1% and 3% NCT regimen for nine days no ocular an
d behaviour changes could be observed. In a pilot study with two volun
teers, treatment with 2.8% NCT for five days caused a self-limited con
junctival injection of one subject, while 1% NCT was well tolerated. S
ubsequently, eight healthy volunteers participated in a phase I clinic
al study. One percent NCT was applied for five days and was well toler
ated by all subjects except for minimal eye burning after the applicat
ion. Because of these positive results, usage of the antimicrobial age
nt NCT in ophthalmology is suggested.