NCT00414739

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
Last Updated

December 22, 2006

Status Verified

December 1, 2006

First QC Date

December 21, 2006

Last Update Submit

December 21, 2006

Conditions

Eye Diseases

Keywords

growth of dendritic cellsprevention

Outcome Measures

Primary Outcomes (1)

  • Possible raised Langerhans cell density in the corneal epithelium

Interventions

Benzalkonium chlorideDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy probands

You may not qualify if:

  • eye diseases
  • pregnancy and lactation period
  • drug dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock, Eye Department

Rostock, 18057, Germany

RECRUITING

Related Publications (6)

  • 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.

    PMID: 10067965BACKGROUND

  • 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.

    PMID: 9561834BACKGROUND

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

    PMID: 11783457BACKGROUND

  • 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.

    PMID: 16371768BACKGROUND

  • 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.

    PMID: 16681079BACKGROUND

  • 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.

    PMID: 15856272BACKGROUND

MeSH Terms

Conditions

Eye Diseases

Interventions

Benzalkonium Compounds

Intervention Hierarchy (Ancestors)

Benzylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Rudolf F. Guthoff, Prof. Dr.

    University of Rostock, Eye Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 22, 2006

Last Updated

December 22, 2006

Record last verified: 2006-12

Locations

DE(1)