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

Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis - a Multi-centre, Randomised, Double-masked, Parallel-group, Phase IV Comparison

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.

Study Overview

• Status: Completed
• Conditions: Blepharitis; Signs and Symptoms
• Intervention / Treatment: Drug: Posiformin 2 %, bibrocathol; Drug: Placebo Comparator

Detailed Description

Reduction of signs and symptoms of blepharitis

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ukraine
  • Kharkov, Ukraine
    • Kharkov District Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis	Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blepharitis signs and symptoms	Changes between baseline and end of treatment in lid edema, lid erythema, debris, pouting of meibomian glands, ocular discomfort, antiseptic effect	14 days

Collaborators and Investigators

• Sponsor: Ursapharm Arzneimittel GmbH
• Investigators: Principal Investigator: Pavel A Bezdetko, Prof., Kharkov District Clinical Hospital

Publications and helpful links

General Publications

• Bezdetko PA, Sergienko N, Dyomin Y, Korol A, Nikitin N, Merzbacher M, Gross D, Kohnen R. Successful treatment of blepharitis with bibrocathol (Posiformin(R) 2 %). Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1869-75. doi: 10.1007/s00417-012-2001-0. Epub 2012 Apr 25.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2011
• Last Update Submitted That Met QC Criteria: May 19, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: blepharitis; Bibrocathol; eye ointment; eye lid
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis
• Other Study ID Numbers: POFOBLE; S67-OPH-081 (Other Identifier: RPS Germany)