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Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis

This study has been completed.
Information provided by:
Ursapharm Arzneimittel GmbH Identifier:
First received: May 18, 2011
Last updated: May 19, 2011
Last verified: May 2011

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.

Condition Intervention Phase
Signs and Symptoms
Drug: Posiformin 2 %, bibrocathol
Drug: Placebo Comparator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Ursapharm Arzneimittel GmbH:

Primary Outcome Measures:
  • Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Changes between baseline and end of treatment in lid edema, lid erythema, debris, pouting of meibomian glands, ocular discomfort, antiseptic effect

Enrollment: 197
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Posiformin 2 %
Eye ointment applied to the eye lid
Drug: Posiformin 2 %, bibrocathol
A strip of 5 mm eye ointment applied 3 times per day to the eye lid
Other Name: Posiformin 2 %, bibrocathol
Placebo Comparator: Placebo
corresponding vehicle, eye ointment applied to the eye lid
Drug: Placebo Comparator
corresponding vehicle, eye ointment applied to the eye lid

Detailed Description:

Reduction of signs and symptoms of blepharitis


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01357538

Kharkov District Clinical Hospital
Kharkov, Ukraine
Sponsors and Collaborators
Ursapharm Arzneimittel GmbH
Principal Investigator: Pavel A Bezdetko, Prof. Kharkov District Clinical Hospital
  More Information

No publications provided by Ursapharm Arzneimittel GmbH

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. P. A. Bezdetko, Kharkov District Clincial Hospital Identifier: NCT01357538     History of Changes
Other Study ID Numbers: POFOBLE, S67-OPH-081, S67-OPH-081
Study First Received: May 18, 2011
Last Updated: May 19, 2011
Health Authority: Ukraine: Ministry of Health

Keywords provided by Ursapharm Arzneimittel GmbH:
eye ointment
eye lid

Additional relevant MeSH terms:
Eye Diseases
Eyelid Diseases processed this record on March 03, 2015