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

Signs and Symptoms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357538
• Other study ID #: POFOBLE
• Secondary ID: S67-OPH-081S67-O
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2011
• Last updated: May 19, 2011
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: May 2011
• Source: Ursapharm Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Reduction of signs and symptoms of blepharitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis
• Signs and Symptoms

Intervention

Drug:
• Posiformin 2 %, bibrocathol
A strip of 5 mm eye ointment applied 3 times per day to the eye lid
• Placebo Comparator
corresponding vehicle, eye ointment applied to the eye lid

Locations

Country	Name	City	State
Ukraine	Kharkov District Clinical Hospital	Kharkov

Sponsors (1)

Lead Sponsor	Collaborator
Ursapharm Arzneimittel GmbH

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes