Clincosm LogoSign in Get a demo

Blephacura Versus Baby Shampoo to Treat Blepharitis

Sponsor
University of Cologne (Other)
Overall Status
Completed
CT.gov ID
NCT01115192
Collaborator
Optima Pharmazeutische GmbH (Other)
144
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
18
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Group A
  • Procedure: Group B
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Blephacura Versus Baby Shampoo to Treat Blepharitis
Actual Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Dec 31, 2010
Actual Study Completion Date :
Dec 31, 2010

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Eye Hospital, University of Cologne Cologne NRW Germany 50937

    Sponsors and Collaborators

    • University of Cologne
    • Optima Pharmazeutische GmbH

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arno Hueber, Blephacura Versus Baby Shampoo to Treat Blepharitis, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT01115192
    Other Study ID Numbers:
    • OptimaCologne
    First Posted:
    May 4, 2010
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2018
    Additional relevant MeSH terms:
    Blepharitis

    Study Results

    No Results Posted as of Nov 19, 2018