NCT01115192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

May 3, 2010

Last Update Submit

November 16, 2018

Conditions

Blepharitis

Study Arms (2)

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

Group APROCEDURE

Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis

Group A
Group BPROCEDURE

Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis

Group B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with blepharitis
  • eyes of 100 patients (50 patients treated with Blephacura, 50 patients treated with diluted baby shampoo) The ratio of female / male is not involved.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital, University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Blephacura Versus Baby Shampoo to Treat Blepharitis

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

May 1, 2010

Primary Completion

December 31, 2010

Study Completion

December 31, 2010

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

DE(1)