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Blephacura Versus Baby Shampoo to Treat Blepharitis

This study has been completed.
Sponsor:
Collaborator:
Optima Pharmazeutische GmbH
Information provided by (Responsible Party):
Arno Hueber, University of Cologne
ClinicalTrials.gov Identifier:
NCT01115192
First received: May 3, 2010
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Blephacura Versus Baby Shampoo to Treat Blepharitis

Further study details as provided by 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115192

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

No publications provided

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
Study First Received: May 3, 2010
Last Updated: April 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013