Blephacura Versus Baby Shampoo to Treat Blepharitis | NCT01115192

Studies
Blephacura Versus Baby Shampoo to Treat Blepharitis

NCT01115192

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Nov 19, 2018Actual

Enrollment

144Actual

Phase

Not Applicable

Conditions

Blepharitis

Interventions

Group A
Group B

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2010Actual

Primary Completion Date

Dec 31, 2010Actual

Completion Date

Dec 31, 2010Actual

First Submitted Date

May 3, 2010

First Submission Date that Met QC Criteria

May 3, 2010

First Posted Date

May 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2018

Last Update Posted Date

Nov 19, 2018Actual

Name	Class
Optima Pharmazeutische GmbH	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

144Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Patients with chronic blepharitis, that will be treated with blephacura	Procedure: Group A
Group B	Experimental	Patients with chronic blepharitis that will be treated with diluted baby shampoo	Procedure: Group B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group A	Procedure	Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis	Group A

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital, University of Cologne		Cologne	North Rhine-Westphalia	50937	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001762	Blepharitis

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided