N-Chlorotaurine - A New Antiviral Agent for Treatment of Adenoviral Keratoconjunctivitis Tested in a Phase 2b Study

Abstract

Abstract: : Purpose: Adenovirus keratokonjuntivitis is the most common viral infection of the ocular surface in many parts of the world. Although usually self-limited, these eye infections may be associated with significant patients' morbidity and major socioeconomic consequences caused by absenteeism from work. The aim of our study was to evaluate the safety and therapeutic efficacy of N-chlorotaurine (NCT) in epidemic keratoconjunctivitis. Methods: NCT is an endogenous oxidant produced by stimulated human leukocytes and has antiviral, antibacterial and antifungal activity. The synthetic sodium salt was used in 1% aqueous solution for treatment of epidemic keratoconjunctivitis. A total of 60 consecutive patients with clinical evidence of adenoviral keratoconjuncivitis were included in a double-blind controlled phase 2b clinical trial. All patients underwent a biomicroscopic examination and a conjunctival swab was taken for investigation of the causative agent by polymerase chain reaction. For evaluation, a clinical score of symtoms was used. The test group was treated with NCT and the control group with gentamycin eye drops every two hours for 7 days. Results: We detected adenoviruses in 55% and enteroviruses in 20% of the patients. Infections by adenoviruses were more severe than those caused by enteroviruses. After one week treatment adenoviruses could be detected no more in 73% of those positive before. In the NCT group a faster improvement of the subjective and objective inflammation symptoms could be observed compared to the control group, although the statistical significance was not achieved due to the heterogenous and small study population. There were no side effects observed except for mild burning in some patients. Conclusion: NCT seems to be effective in epidemic keratoconjunctivitis especially if treatment is started early. These results are encouraging for further studies to investigate the efficacy in a larger population.

Keywords: adenovirus • conjunctivitis • antibiotics/antifungals/antiparasitics