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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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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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Detailed Description

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Reduction of signs and symptoms of blepharitis

Conditions

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Blepharitis Signs and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Posiformin 2 %

Eye ointment applied to the eye lid

Group Type ACTIVE_COMPARATOR

Posiformin 2 %, bibrocathol

Intervention Type DRUG

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

Placebo

corresponding vehicle, eye ointment applied to the eye lid

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

corresponding vehicle, eye ointment applied to the eye lid

Interventions

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Posiformin 2 %, bibrocathol

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

Intervention Type DRUG

Placebo Comparator

corresponding vehicle, eye ointment applied to the eye lid

Intervention Type DRUG

Eligibility Criteria

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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