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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 because the information has not been verified recently.
Verified December 2006 by University of Rostock.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
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
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014