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

This study has been completed.
Sponsor:
Information provided by:
Ursapharm Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01357538
First received: May 18, 2011
Last updated: May 19, 2011
Last verified: May 2011
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Ursapharm Arzneimittel GmbH

Additional 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
Study First Received: May 18, 2011
Last Updated: May 19, 2011
Health Authority: Ukraine: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 23, 2014