Tolerability of N-chlorotaurine plus ammonium chloride in the rabbit and human eye - A phase 1 clinical study

Graefe's Archive for Clinical and Experimental Ophthalmology

Volumn 246, Issue 12, 2008, Pages 1723-1730

  Teuchner, Barbara ^a   Schmid, Eduard ^a   Ulmer, Hanno ^a   Gottardi, Waldemar ^a   Nagl, Markus ^a  

^a INNSBRUCK MEDICAL UNIVERSITY   (Austria)

Author keywords

Active chlorine compounds; Ammonium chloride; Clinical trial; Conjunctivitis; Monochloramine; N chlorotaurine; Oxidants; Rabbit model; Tolerability

Indexed keywords

AMMONIUM CHLORIDE; ANTIINFECTIVE AGENT; EYE DROPS; N CHLOROTAURINE; UNCLASSIFIED DRUG;

ABNORMAL SENSATION; ADULT; AGED; ANIMAL EXPERIMENT; ARTICLE; BULBUS OCULI ALTERATION; BURNING SENSATION; CLINICAL TRIAL; CONJUNCTIVA DISEASE; CONJUNCTIVAL INJECTION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORNEA DISEASE; CORNEA ENDOTHELIUM; CORNEAL STIPPLING; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRY EYE; EXPERIMENTAL RABBIT; EYE BURNING SENSATION; EYE LAVAGE; EYEBALL; FEMALE; FOREIGN BODY SENSATION; HUMAN; HUMAN EXPERIMENT; MALE; NONHUMAN; NORMAL HUMAN; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VISUAL ACUITY; VISUAL IMPAIRMENT;

AMMONIUM CHLORIDE; ANIMALS; ANTI-INFECTIVE AGENTS, LOCAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; EYE; HUMANS; OPHTHALMIC SOLUTIONS; PAIN; PILOT PROJECTS; RABBITS; TAURINE; TIME FACTORS;

EID: 56049126870     PISSN: 0721832X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00417-008-0900-x     Document Type: Article

References (26)

1. Gottardi W, Arnitz R, Nagl M (2007) N-chlorotaurine and ammonium chloride: An antiseptic preparation with strong bactericidal activity. Int J Pharm 335:32-40, doi: 10.1016/j.ijpharm.2006.11.003
2. Gottardi W, Nagl M (2002) Chemical properties of N-chlorotaurine sodium, a key compound in the human defence system. Arch Pharm Pharm Med Chem 335:411-421, doi: 10.1002/ 1521-4184(200212)335:9<411::AID-ARDP411>3.0.CO;2-D
3. Grisham MB, Jefferson MM, Melton DF, Thomas EL (1984) Chlorination of endogenous amines by isolated neutrophils. J Biol Chem 259:10404-10413
4. Jauch A, Fsadni M, Gamba G (1999) Meta-analysis of six clinical phase III studies comparing lomefloxacin 0.3% eye drops twice daily to five standard antibiotics in patients with acute bacterial conjunctivitis. Graefes Arch Clin Exp Ophthalmol 237:705-713, doi: 10.1007/s004170050300
5. Kinchington PR, Romanowski EG, Gordon YJ (2005) Prospects for adenovirus antivirals. J Antimicrob Chemother 55:424-429, doi: 10.1093/jac/dki057
6. Nagl M, Gottardi W (1992) In vitro experiments on the bactericidal action of N-chlorotaurine. Hyg Med 17:431-439
7. Nagl M, Gottardi W (1996) Enhancement of the bactericidal efficacy of N-chlorotaurine by inflammation samples and selected N-H compounds. Hyg Med 21:597-605
8. Nagl M, Gottardi W (1998) Rapid killing of Mycobacterium terrae by N-chlorotaurine in presence of ammonium is caused by the reaction product monochloramine. J Pharm Pharmacol 50:1317-1320
9. Nagl M, Gruber A, Fuchs A, Lell C, Lemberger EM, Borg-von Zepelin M et al (2002) Impact of N-chlorotaurine on viability and production of secreted aspartyl proteinases of Candida spp. Antimicrob Agents Chemother 46:1996-1999, doi: 10.1128/AAC.46.6.1996-1999.2002
10. Nagl M, Hengster P, Semenitz E, Gottardi W (1999) The postantibiotic effect of N-chlorotaurine on Staphylococcus aureus. Application in the mouse peritonitis model. J Antimicrob Chemother 43:805-809, doi: 10.1093/ jac/43.6.805
11. Nagl M, Hess M, Pfaller K, Hengster P, Gottardi W (2000) Bactericidal activity of micromolar N-chlorotaurine - evidence for its antimicrobial function in the human defence system. Antimicrob Agents Chemother 44:2507-2513, doi: 10.1128/AAC.44.9.2507-2513.2000
12. Nagl M, Larcher C, Gottardi W (1998) Activity of N-chlorotaurine against herpes simplex- and adenoviruses. Antiviral Res 38:25-30, doi: 10.1016/ S0166-3542(98)00005-9
13. Nagl M, Lass-Floerl C, Neher A, Gunkel AR, Gottardi W (2001) Enhanced fungicidal activity of N-chlorotaurine in nasal secretion. J Antimicrob Chemother 47:871-874, doi: 10.1093/jac/47.6.871
14. Nagl M, Miller B, Daxecker F, Ulmer H, Gottardi W (1998) Tolerance of N-chlorotaurine, an endogenous antimicrobial agent, in the rabbit and human eye - a phase I clinical study. J Ocul Pharmacol Ther 14:283-290
15. Nagl M, Nguyen VA, Gottardi W, Ulmer H, Höpfl R (2003) Tolerability and efficacy of N-chlorotaurine compared to chloramine T for treatment of chronic leg ulcers with purulent coating. Br J Dermatol 149:590-597, doi: 10.1046/j.1365-2133.2003.05432.x
16. Nagl M, Pfausler B, Schmutzhard E, Fille M, Gottardi W (1998) Tolerance and bactericidal action of N-chlorotaurine in a urinary tract infection by an omniresistant Pseudomonas aeruginosa. Zentralbl Bakteriol 288:217-223
17. Nagl M, Teuchner B, Pöttinger E, Ulmer H, Gottardi W (2000) Tolerance of N-chlorotaurine, a new antimicrobial agent, in infectious conjunctivitis - a phase II pilot study. Ophthalmologica 214:111-114, doi: 10.1159/000027477
18. Neher A, Fischer H, Appenroth E, Lass-Floerl C, Mayr A, Gschwendtner A et al (2005) Tolerability of N-Chlorotaurine in Chronic Rhinosinusitis Applied via Yamik Catheter. Auris Nasus Larynx 32:359-364, doi: 10.1016/ j.anl.2005.05.006
19. Neher A, Nagl M, Appenroth E, Gstottner M, Wischatta M, Reisigl F et al (2004) Acute Otitis Externa: Efficacy and Tolerability of N-Chlorotaurine, a Novel Endogenous Antiseptic Agent. Laryngoscope 114:850-854, doi: 10.1097/00005537-200405000-00011
20. Notivol R, Martinez M, Bergamini MV (1994) Treatment of chronic nonbacterial conjunctivitis with a cyclo-oxygenase inhibitor or a corticosteroid. Pranoprofen Study Group. Am J Ophthalmol 117:651-656
21. Rand MC, Greenberg AE, Taras MJ (1979) Iodometric method I. In: Rand MC, Greenberg AE, Taras MJ (eds) Standard methods for examination of water and wastewater. American Public Health Association, Washington DC, pp 316-318
22. Romanowski EG, Yates KA, Teuchner B, Nagl M, Gottardi W, Gordon YJ (2002) In vitro evaluation of the new antimicrobial agent N-chlorotaurine (NCT) against ocular isolates of adenovirus. Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO); 5 May 2002, Fort Lauderdale, Florida
23. Romanowski EG, Yates KA, Teuchner B, Nagl M, Irschick EU, Gordon YJ (2006) N-Chlorotaurine is an effective antiviral agent against adenovirus in vitro and in the Ad5/NZW rabbit ocular model. Invest Ophthalmol Vis Sci 47:2021-2026, doi: 10.1167/iovs.05-1270
24. Stelmaszynska T, Zgliczynski JM (1974) Myeloperoxidase of human neutrophilic granulocytes as chlorinating enzyme. Eur J Biochem 45:305-312, doi: 10.1111/j.1432-1033.1974.tb03555.x
25. Teuchner B, Nagl M, Schidlbauer A, Ishiko H, Dragosits E, Ulmer H et al (2005) Tolerability and efficacy of N-chlorotaurine in epidemic keratoconjunctivitis - a double-blind randomized phase 2 clinical trial. J Ocul Pharmacol Ther 21:157-165, doi: 10.1089/jop.2005.21.157
26. Unterberger I, Spiss H, Brandauer E, Engelhardt K, Pfausler B, Kampfl A et al (2001) N-chlorotaurine - local antibacterial therapy in urinary tract infections by omniresistant Pseudomonas aeruginosa. Twenty-First Annual Conference of the Arbeitsgemeinschaft Neurologische Intensivmedizin (ANIM); 18 Jan 2001, Innsbruck, Austria