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
  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
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: 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
Eye Diseases
Eyelid Diseases

ClinicalTrials.gov processed this record on October 23, 2014