Tolerability and efficacy of N-chlorotaurine in epidemic keratoconjunctivitis--a double-blind, randomized, phase-2 clinical trial.
The aim of this study was to assess the tolerability and efficacy of N-chlorotaurine (NCT), an endogenous antimicrobial agent, in epidemic keratoconjunctivitis. In a prospective double-blind, randomized phase 2b study, the infected eyes were treated for 7 days with eye drops containing 1% aqueous solution of N-chlorotaurine (33 subjects) or gentamicin (27 subjects, control group). Adenovirus types 3, 4, 8, 19, and 37 were detected in 39 subjects (65%), enteroviruses in 8 (13.3%), and staphylococci in 5 (8.3%). Subjective and objective symptoms were scaled and added to a subjective and objective score, respectively, on day 1 (baseline), day 4, and day 8. Analyzing the whole study population, the subjective score on day 8 was lower in the NCT group (P = 0.016), whereas there were no differences in the objective score. However, in severe infections caused by adenovirus type 8 (n = 20) both the subjective and objective score were lower in the NCT group on day 4 (P = 0.003 and 0.015, respectively), which was also true for the subjective score on day 8 (P = 0.004) in this subgroup. The frequency of subepithelial infiltrates was similar in both groups. N-chlorotaurine was well-tolerated, shortened the duration of illness, and seems to be a useful causative therapeutic approach in severe epidemic keratoconjunctivitis.
Teuchner
Barbara
B
Department of Ophthalmology, Innsbruck Medical University, Innsbruck, Austria.
Nagl
Markus
M
Schidlbauer
Axel
A
Ishiko
Hiroaki
H
Dragosits
Ernst
E
Ulmer
Hanno
H
Aoki
Koki
K
Ohno
Shigeaki
S
Mizuki
Nobuhisa
N
Gottardi
Waldemar
W
Larcher
Clara
C
D000256:Adenoviridae / Q000187:drug effects / Q000302:isolation & purification; D000257:Adenoviridae Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004196:Disease Outbreaks; D004311:Double-Blind Method; D004770:Enterovirus / Q000187:drug effects / Q000302:isolation & purification; D004769:Enterovirus Infections / Q000188:drug therapy / Q000453:epidemiology / Q000821:virology; D005260:Female; D005839:Gentamicins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007637:Keratoconjunctivitis / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology / Q000821:virology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013203:Staphylococcal Infections / Q000188:drug therapy / Q000453:epidemiology / Q000382:microbiology; D013211:Staphylococcus aureus / Q000187:drug effects / Q000302:isolation & purification; D013654:Taurine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D000998:Antiviral Agents; D005839:Gentamicins; D013654:Taurine; C043410:N-chlorotaurine