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

December 21, 2006 updated by: University of Rostock
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • Recruiting
        • University of Rostock, Eye Department
        • Contact:
        • Principal Investigator:
          • Andrey Zhivov, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy probands

Exclusion Criteria:

  • eye diseases
  • pregnancy and lactation period
  • drug dependency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Possible raised Langerhans cell density in the corneal epithelium

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Rudolf F. Guthoff, Prof. Dr., University of Rostock, Eye Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

December 22, 2006

Last Update Submitted That Met QC Criteria

December 21, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAC-2006-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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