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

Ursapharm Arzneimittel GmbH197 enrolled

Overview

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.

Reduction of signs and symptoms of blepharitis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

197

Conditions

Blepharitis Signs and Symptoms

Interventions

Posiformin 2 %, bibrocatholDRUG

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

Placebo ComparatorDRUG

corresponding vehicle, eye ointment applied to the eye lid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kharkov District Clinical Hospital

Kharkiv, Ukraine

Outcomes

Primary Outcomes

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

Time frame: 14 days

Secondary Outcomes

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

Time frame: 14 days

Data from ClinicalTrials.gov

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