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

NCT ID: NCT00414739

Last Updated: 2006-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Eye Diseases

Keywords

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growth of dendritic cells prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Benzalkonium chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy probands

Exclusion Criteria

* eye diseases
* pregnancy and lactation period
* drug dependency
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role lead

Principal Investigators

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Rudolf F. Guthoff, Prof. Dr.

Role: STUDY_CHAIR

University of Rostock, Eye Department

Locations

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University of Rostock, Eye Department

Rostock, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Rudolf F. Guthoff, Prof. Dr.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 10067965 (View on PubMed)

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. doi: 10.1080/02713689808951223.

Reference Type BACKGROUND
PMID: 9561834 (View on PubMed)

Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. doi: 10.1007/BF02853166.

Reference Type BACKGROUND
PMID: 11783457 (View on PubMed)

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. doi: 10.1097/01.ico.0000170694.90455.f7.

Reference Type BACKGROUND
PMID: 16371768 (View on PubMed)

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. doi: 10.1016/s1542-0124(12)70030-7.

Reference Type BACKGROUND
PMID: 16681079 (View on PubMed)

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. doi: 10.1007/s00417-004-1075-8. Epub 2005 Oct 20.

Reference Type BACKGROUND
PMID: 15856272 (View on PubMed)

Other Identifiers

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BAC-2006-1

Identifier Type: -

Identifier Source: org_study_id