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

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ClinicalTrials.gov Identifier: NCT01357538
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : May 20, 2011
Sponsor:
Information provided by:
Ursapharm Arzneimittel GmbH

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.

Condition or disease Intervention/treatment Phase
Blepharitis Signs and Symptoms Drug: Posiformin 2 %, bibrocathol Drug: Placebo Comparator Phase 4

Detailed Description:
Reduction of signs and symptoms of blepharitis

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: May 20, 2011    Key Record Dates
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:
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Blepharitis
Signs and Symptoms
Eyelid Diseases
Eye Diseases