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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01357538

Enrollment

197

Registered

2011-05-20

Start date

2009-02-28

Completion date

2009-08-31

Last updated

2011-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharitis, Signs and Symptoms

Keywords

Bibrocathol, eye ointment, blepharitis, eye lid

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.

Detailed description

Reduction of signs and symptoms of blepharitis

Interventions

DRUGPosiformin 2 %, bibrocathol

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

DRUGPlacebo Comparator

corresponding vehicle, eye ointment applied to the eye lid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026