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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by University of Rostock.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414739
First Posted: December 22, 2006
Last Update Posted: December 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Rostock
  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
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • Possible raised Langerhans cell density in the corneal epithelium

Estimated Enrollment: 20
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy probands

Exclusion Criteria:

  • eye diseases
  • pregnancy and lactation period
  • drug dependency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Sharp & Dohme Corp.
Investigators
Study Chair: Rudolf F. Guthoff, Prof. Dr. University of Rostock, Eye Department
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00414739     History of Changes
Other Study ID Numbers: BAC-2006-1
First Submitted: December 21, 2006
First Posted: December 22, 2006
Last Update Posted: December 22, 2006
Last Verified: December 2006

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