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Blephacura Versus Baby Shampoo to Treat Blepharitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115192
First Posted: May 4, 2010
Last Update Posted: April 24, 2013
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:
Optima Pharmazeutische GmbH
Information provided by (Responsible Party):
Arno Hueber, University of Cologne
  Purpose
The aim of the study is to compare the effectiveness in treatment of chronic blepharitis either with a phospholipid liposome suspension compared to a conventional therapy recommendation using diluted baby shampoo.

Condition Intervention
Blepharitis Procedure: Group A Procedure: Group B

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Blephacura Versus Baby Shampoo to Treat Blepharitis

Further study details as provided by Arno Hueber, University of Cologne:

Enrollment: 144
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Patients with chronic blepharitis, that will be treated with blephacura
Procedure: Group A
Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis
Experimental: Group B
Patients with chronic blepharitis that will be treated with diluted baby shampoo
Procedure: Group B
Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with blepharitis
  • 100 eyes of 100 patients (50 patients treated with Blephacura, 50 patients treated with diluted baby shampoo) The ratio of female / male is not involved.

Exclusion Criteria:

  • all patients that are not included in the group of inclusion criteria
  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): NCT01115192


Locations
Germany
University Eye Hospital, University of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University of Cologne
Optima Pharmazeutische GmbH
  More Information

Responsible Party: Arno Hueber, Blephacura Versus Baby Shampoo to Treat Blepharitis, University of Cologne
ClinicalTrials.gov Identifier: NCT01115192     History of Changes
Other Study ID Numbers: OptimaCologne
First Submitted: May 3, 2010
First Posted: May 4, 2010
Last Update Posted: April 24, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases