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CompletedNCT01115192Updated Nov 19, 2018

Blephacura Versus Baby Shampoo to Treat Blepharitis

An interventional study of Group A and Group B in Blepharitis, sponsored by University of Cologne. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by University of Cologne · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Blepharitis

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03

In context

Blepharitis

73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.

This study's enrollment of 144 is above the median of 60 across 65 interventional studies indexed under Blepharitis.

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Lead sponsor

University of Cologne is the lead sponsor of 203 studies on the registry; 26 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • all patients that are not included in the group of inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    Group A

    Patients with chronic blepharitis, that will be treated with blephacura

    Procedure: Group A

  • Experimental
    Group B

    Patients with chronic blepharitis that will be treated with diluted baby shampoo

    Procedure: Group B

Interventions

  • ProcedureGroup A

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

  • ProcedureGroup B

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

06

Study locations

1 site
  • University Eye Hospital, University of Cologne
    Cologne, NRW 50937, Germany
07

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2010 to primary completion in Dec 2010, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 3, 2010
First posted
May 4, 2010
StartActual
May 1, 2010
Primary completionActual
Dec 31, 2010
CompletionActual
Dec 31, 2010
Last update
Nov 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01115192
Lead sponsor
University of Cologne
Collaborators
Optima Pharmazeutische GmbH
Responsible party
Arno Hueber (Blephacura Versus Baby Shampoo to Treat Blepharitis, University of Cologne) — Principal investigator
First posted
May 4, 2010
Start date
May 1, 2010
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010
Last update
Nov 19, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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