BlepharitisNCT01115192
Blephacura Versus Baby Shampoo to Treat Blepharitis
A study testing Group A and Group B in people with Blepharitis, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blepharitis
- What is being tested?
- Group A and Group B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2010to 31 Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- all patients that are not included in the group of inclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Eye Hospital, University of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
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.
- Conditions
- Blepharitis
- Being tested
- Group A, Group B
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AProcedure or surgery
Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis
Group BProcedure or surgery
Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients with chronic blepharitis, that will be treated with blephacura Receives: Procedure: Group A |
| Group B | Experimental | Patients with chronic blepharitis that will be treated with diluted baby shampoo Receives: Procedure: Group B |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study start1 May 2010
- Primary completion31 Dec 2010
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Optima Pharmazeutische GmbH
- Responsible party
- Principal investigator, Arno Hueber, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115192
- Sponsor's protocol ID
- OptimaCologne
- Status last verified
- Nov 2018
- First submitted
- 3 May 2010
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blephacura Versus Baby Shampoo to Treat Blepharitis
- ClinicalTrials.gov ID
- NCT01115192
- Acronym / sponsor ID
- OptimaCologne
- Conditions
- Blepharitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Optima Pharmazeutische GmbH
- Study start
- 1 May 2010 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Group APatients with chronic blepharitis, that will be treated with blephacura |
| Group B | Experimental | Procedure: Group BPatients with chronic blepharitis that will be treated with diluted baby shampoo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- all patients that are not included in the group of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group ABlephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis | Procedure or surgery | Group A |
| Group BDiluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis | Procedure or surgery | Group B |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Blepharitis, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.