Tolerability and efficacy of N-chlorotaurine in epidemic keratoconjunctivitis--a double-blind, randomized, phase-2 clinical trial

J Ocul Pharmacol Ther. 2005 Apr;21(2):157-65. doi: 10.1089/jop.2005.21.157.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenoviridae / drug effects
  • Adenoviridae / isolation & purification
  • Adenoviridae Infections / drug therapy*
  • Adenoviridae Infections / epidemiology
  • Adenoviridae Infections / virology
  • Adolescent
  • Adult
  • Aged
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Child
  • Disease Outbreaks*
  • Double-Blind Method
  • Enterovirus / drug effects
  • Enterovirus / isolation & purification
  • Enterovirus Infections / drug therapy
  • Enterovirus Infections / epidemiology
  • Enterovirus Infections / virology
  • Female
  • Gentamicins / administration & dosage
  • Gentamicins / adverse effects
  • Gentamicins / therapeutic use
  • Humans
  • Keratoconjunctivitis / drug therapy*
  • Keratoconjunctivitis / epidemiology
  • Keratoconjunctivitis / microbiology
  • Keratoconjunctivitis / virology
  • Male
  • Middle Aged
  • Prospective Studies
  • Staphylococcal Infections / drug therapy
  • Staphylococcal Infections / epidemiology
  • Staphylococcal Infections / microbiology
  • Staphylococcus aureus / drug effects
  • Staphylococcus aureus / isolation & purification
  • Taurine / administration & dosage
  • Taurine / adverse effects
  • Taurine / analogs & derivatives*
  • Taurine / therapeutic use*

Substances

  • Anti-Bacterial Agents
  • Antiviral Agents
  • Gentamicins
  • Taurine
  • N-chlorotaurine