Testing of Innocuousness of Benzalkonium Chloride on the Eye Concerning Possible Growth of Langerhans Cells

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2006 by University of Rostock.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Merck

Information provided by:

University of Rostock

ClinicalTrials.gov Identifier:

NCT00414739

First received: December 21, 2006

Last updated: NA

Last verified: December 2006

History: No changes posted

Purpose

The study analysis the influence of benzalkonium chloride on the density of antigen presenting Langerhans cells. This is achieved in a double blind randomized study using in-vivo confocal microscopy to identify and quantify Langerhans cells of the human cornea in its central and peripheral part. This study design is based on observations with raised Langerhans cell density after the application of benzalkonium chloride containing eye drops in glaucoma patients.

Condition	Intervention	Phase
Eye Diseases	Drug: Benzalkonium chloride	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases

Drug Information available for: Chlorine Benzalkonium chloride

U.S. FDA Resources

Further study details as provided by University of Rostock:

Primary Outcome Measures:

Possible raised Langerhans cell density in the corneal epithelium

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy probands

Exclusion Criteria:

eye diseases
pregnancy and lactation period
drug dependency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414739

Locations

Germany
University of Rostock, Eye Department	Recruiting
Rostock, Germany, 18057
Contact: Rudolf F. Guthoff, Prof. Dr. +49/(0)381/4948501 rudolf.guthoff@med.uni-rostock.de
Principal Investigator: Andrey Zhivov, Dr. med.

Sponsors and Collaborators

University of Rostock

Merck

Investigators

Study Chair:

Rudolf F. Guthoff, Prof. Dr.

University of Rostock, Eye Department

More Information

Publications:

De Saint Jean M, Brignole F, Bringuier AF, Bauchet A, Feldmann G, Baudouin C. Effects of benzalkonium chloride on growth and survival of Chang conjunctival cells. Invest Ophthalmol Vis Sci. 1999 Mar;40(3):619-30.

Becquet F, Goldschild M, Moldovan MS, Ettaiche M, Gastaud P, Baudouin C. Histopathological effects of topical ophthalmic preservatives on rat corneoconjunctival surface. Curr Eye Res. 1998 Apr;17(4):419-25.

Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. Review.

Eckard A, Stave J, Guthoff RF. In vivo investigations of the corneal epithelium with the confocal Rostock Laser Scanning Microscope (RLSM). Cornea. 2006 Feb;25(2):127-31.

Zhivov A, Stachs O, Kraak R, Stave J, Guthoff RF. In vivo confocal microscopy of the ocular surface. Ocul Surf. 2006 Apr;4(2):81-93. Review.

Zhivov A, Stave J, Vollmar B, Guthoff R. In vivo confocal microscopic evaluation of Langerhans cell density and distribution in the normal human corneal epithelium. Graefes Arch Clin Exp Ophthalmol. 2005 Oct;243(10):1056-61. Epub 2005 Oct 20.

ClinicalTrials.gov Identifier:	NCT00414739 History of Changes
Other Study ID Numbers:	BAC-2006-1
Study First Received:	December 21, 2006
Last Updated:	December 21, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Rostock:

growth of dendritic cells
prevention

Additional relevant MeSH terms:

Eye Diseases
Benzalkonium Compounds
Anti-Infective Agents, Local

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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