Back to resultsEfficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis
Primary Purpose
Blepharitis, Signs and Symptoms
Status
Completed
Phase
Phase 4
Locations
Ukraine
Study Type
Interventional
Intervention
Posiformin 2 %, bibrocathol
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Blepharitis focused on measuring Bibrocathol, eye ointment, blepharitis, eye lid
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- different ocular conditions
- different system conditions
- several concomitant medications
Sites / Locations
- Kharkov District Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Posiformin 2 %
Placebo
Arm Description
Eye ointment applied to the eye lid
corresponding vehicle, eye ointment applied to the eye lid
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01357538
Brief Title
Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ursapharm Arzneimittel GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Reduction of signs and symptoms of blepharitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis, Signs and Symptoms
Keywords
Bibrocathol, eye ointment, blepharitis, eye lid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Posiformin 2 %
Arm Type
Active Comparator
Arm Description
Eye ointment applied to the eye lid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
corresponding vehicle, eye ointment applied to the eye lid
Intervention Type
Drug
Intervention Name(s)
Posiformin 2 %, bibrocathol
Intervention Description
A strip of 5 mm eye ointment applied 3 times per day to the eye lid
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
corresponding vehicle, eye ointment applied to the eye lid
Primary Outcome Measure Information:
Title
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
Description
Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Changes in blepharitis signs and symptoms
Description
Changes between baseline and end of treatment in lid edema, lid erythema, debris, pouting of meibomian glands, ocular discomfort, antiseptic effect
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
different ocular conditions
different system conditions
several concomitant medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel A Bezdetko, Prof.
Organizational Affiliation
Kharkov District Clinical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kharkov District Clinical Hospital
City
Kharkov
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
22527308
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis
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