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

Primary Purpose

Eye Diseases

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Benzalkonium chloride
Sponsored by
University of Rostock
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Diseases focused on measuring growth of dendritic cells, prevention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy probands

Exclusion Criteria:

  • eye diseases
  • pregnancy and lactation period
  • drug dependency

Sites / Locations

  • University of Rostock, Eye DepartmentRecruiting

Outcomes

Primary Outcome Measures

Possible raised Langerhans cell density in the corneal epithelium

Secondary Outcome Measures

Full Information

First Posted
December 21, 2006
Last Updated
December 21, 2006
Sponsor
University of Rostock
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00414739
Brief Title
Testing of Innocuousness of Benzalkonium Chloride on the Eye Concerning Possible Growth of Langerhans Cells
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rostock
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
growth of dendritic cells, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Benzalkonium chloride
Primary Outcome Measure Information:
Title
Possible raised Langerhans cell density in the corneal epithelium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy probands Exclusion Criteria: eye diseases pregnancy and lactation period drug dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf F. Guthoff, Prof. Dr.
Organizational Affiliation
University of Rostock, Eye Department
Official's Role
Study Chair
Facility Information:
Facility Name
University of Rostock, Eye Department
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rudolf F. Guthoff, Prof. Dr.
Phone
+49/(0)381/4948501
Email
rudolf.guthoff@med.uni-rostock.de
First Name & Middle Initial & Last Name & Degree
Andrey Zhivov, Dr. med.

12. IPD Sharing Statement

Citations:
PubMed Identifier
10067965
Citation
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.
Results Reference
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PubMed Identifier
9561834
Citation
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.
Results Reference
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PubMed Identifier
11783457
Citation
Noecker R. Effects of common ophthalmic preservatives on ocular health. Adv Ther. 2001 Sep-Oct;18(5):205-15. doi: 10.1007/BF02853166.
Results Reference
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PubMed Identifier
16371768
Citation
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.
Results Reference
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PubMed Identifier
16681079
Citation
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.
Results Reference
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PubMed Identifier
15856272
Citation
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.
Results Reference
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Testing of Innocuousness of Benzalkonium Chloride on the Eye Concerning Possible Growth of Langerhans Cells

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