Back to resultsBlephacura Versus Baby Shampoo to Treat Blepharitis
Primary Purpose
Blepharitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis
Eligibility 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
Sites / Locations
- University Eye Hospital, University of Cologne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Patients with chronic blepharitis, that will be treated with blephacura
Patients with chronic blepharitis that will be treated with diluted baby shampoo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01115192
First Posted
May 3, 2010
Last Updated
November 16, 2018
Sponsor
University of Cologne
Collaborators
Optima Pharmazeutische GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01115192
Brief Title
Blephacura Versus Baby Shampoo to Treat Blepharitis
Official Title
Blephacura Versus Baby Shampoo to Treat Blepharitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
December 31, 2010 (Actual)
Study Completion Date
December 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
Collaborators
Optima Pharmazeutische GmbH
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients with chronic blepharitis, that will be treated with blephacura
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients with chronic blepharitis that will be treated with diluted baby shampoo
Intervention Type
Procedure
Intervention Name(s)
Group A
Intervention Description
Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis
Intervention Type
Procedure
Intervention Name(s)
Group B
Intervention Description
Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Eye Hospital, University of Cologne
City
Cologne
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Blephacura Versus Baby Shampoo to Treat Blepharitis
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