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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357538
First Posted: May 20, 2011
Last Update Posted: May 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ursapharm Arzneimittel GmbH
  Purpose
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
Blepharitis Signs and Symptoms Drug: Posiformin 2 %, bibrocathol Drug: Placebo Comparator Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:


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 ]
    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 ]
    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
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357538


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. P. A. Bezdetko, Kharkov District Clincial Hospital
ClinicalTrials.gov Identifier: NCT01357538     History of Changes
Other Study ID Numbers: POFOBLE
S67-OPH-081
S67-OPH-081 ( Other Identifier: RPS Germany )
First Submitted: May 18, 2011
First Posted: May 20, 2011
Last Update Posted: May 20, 2011
Last Verified: May 2011

Keywords provided by Ursapharm Arzneimittel GmbH:
Bibrocathol
eye ointment
blepharitis
eye lid

Additional relevant MeSH terms:
Signs and Symptoms
Blepharitis
Eyelid Diseases
Eye Diseases