BlepharitisPhase 4NCT01357538
Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis
A Phase 4 study testing Posiformin 2 %, bibrocathol in people with Blepharitis and Signs and Symptoms, run by Ursapharm Arzneimittel GmbH at 1 site in Ukraine.
Trial summary
This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis, Signs and Symptoms
- What is being tested?
- Posiformin 2 %, bibrocathol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteUkraine
- Study dates
- Feb 2009to Aug 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- ambulatory male and female patients 18 years of age or older
- summarised score of signs and symptoms of blepharitis of 15 or more at baseline
Who cannot join
- different ocular conditions
- different system conditions
- several concomitant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis - a Multi-centre, Randomised, Double-masked, Parallel-group, Phase IV Comparison
This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.
Read the detailed description
Reduction of signs and symptoms of blepharitis
- Conditions
- Blepharitis, Signs and Symptoms
- Being tested
- Posiformin 2 %, bibrocathol, Placebo Comparator
- Keywords
- Bibrocathol, eye ointment, blepharitis, eye lid
- Medical subject headings
- Blepharitis, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posiformin 2 %, bibrocatholDrug
A strip of 5 mm eye ointment applied 3 times per day to the eye lid
Placebo ComparatorDrug
corresponding vehicle, eye ointment applied to the eye lid
| Study group | Role | What they receive |
|---|---|---|
| Posiformin 2 % | Active comparator | Eye ointment applied to the eye lid Receives: Drug: Posiformin 2 %, bibrocathol |
| Placebo | Placebo comparator | corresponding vehicle, eye ointment applied to the eye lid Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination
Measured: 14 days
Secondary outcomes (1)
Changes in blepharitis signs and symptoms
Changes between baseline and end of treatment in lid edema, lid erythema, debris, pouting of meibomian glands, ocular discomfort, antiseptic effect
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ursapharm Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pavel A Bezdetko, Prof., Principal investigator, Kharkov District Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357538
- Sponsor's protocol ID
- POFOBLE
- Other IDs
- S67-OPH-081, S67-OPH-081
- Status last verified
- May 2011
- First submitted
- 18 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Bezdetko PA, Sergienko N, Dyomin Y, Korol A, Nikitin N, Merzbacher M, Gross D, Kohnen R. Successful treatment of blepharitis with bibrocathol (Posiformin(R) 2 %). Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1869-75. doi: 10.1007/s00417-012-2001-0. Epub 2012 Apr 25.
PubMed 22527308
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis - a Multi-centre, Randomised, Double-masked, Parallel-group, Phase IV Comparison
- ClinicalTrials.gov ID
- NCT01357538
- Acronym / sponsor ID
- POFOBLE
- Conditions
- Blepharitis, Signs and Symptoms
- Keywords
- Bibrocathol, eye ointment, blepharitis, eye lid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Ursapharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 May 2011 (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.
This is a multicentre, randomised, double-masked, parallel-group, phase IV comparison of Posiformin 2 % eye ointment (active substance: bibrocathol) in the treatment of blepharitis.
Detailed description
Reduction of signs and symptoms of blepharitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posiformin 2 % | Active comparator | Drug: Posiformin 2 %, bibrocatholEye ointment applied to the eye lid |
| Placebo | Placebo comparator | Drug: Placebo Comparatorcorresponding vehicle, eye ointment applied to the eye lid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- written informed consent
- ambulatory male and female patients 18 years of age or older
- summarised score of signs and symptoms of blepharitis of 15 or more at baseline
Key exclusion criteria (3 listed)
- different ocular conditions
- different system conditions
- several concomitant medications
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 |
|---|---|---|
| Posiformin 2 %, bibrocatholA strip of 5 mm eye ointment applied 3 times per day to the eye lid | Drug | Posiformin 2 % |
| Placebo Comparatorcorresponding vehicle, eye ointment applied to the eye lid | Drug | Placebo |
Primary outcome
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
Time frame: 14 days
Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination
1 secondary outcome
Changes in blepharitis signs and symptoms
Time frame: 14 days
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 20 May 2011.
- Derived from this study: PubMed 22527308Bezdetko PA, Sergienko N, Dyomin Y, Korol A, Nikitin N, Merzbacher M, Gross D, Kohnen R. Successful treatment of blepharitis with bibrocathol (Posiformin(R) 2 %). Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1869-75. doi: 10.1007/s00417-012-2001-0. Epub 2012 Apr 25.
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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.
Pavel A Bezdetko, Prof. principal investigator
Kharkov District Clinical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Posiformin 2 %, bibrocathol in people with Blepharitis and Signs and Symptoms, run by Ursapharm Arzneimittel GmbH at 1 site in Ukraine.
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 3 inclusion and 3 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 20 May 2011. 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 Ukraine. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357538, which also lists 1 linked publication.
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 20 May 2011.