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Completed

NCT Number: NCT01357538

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

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.

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kharkov District Clinical Hospital

Kharkiv, Ukraine

About this study

Reduction of signs and symptoms of blepharitis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posiformin 2 %, bibrocathol

Drug

A strip of 5 mm eye ointment applied 3 times per day to the eye lid

placebo comparator

Drug

corresponding vehicle, eye ointment applied to the eye lid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ursapharm Arzneimittel GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 20, 2011
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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