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

Sponsor

Ursapharm Arzneimittel GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01357538

Collaborator

(none)

197

Enrollment

Location

Arms

5.9

Duration (Months)

33.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blepharitis Signs and Symptoms	Drug: Posiformin 2 %, bibrocathol Drug: Placebo Comparator	Phase 4

Detailed Description

Reduction of signs and symptoms of blepharitis

Study Design

Study Type:

Interventional

Actual Enrollment :

197 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kharkov District Clinical Hospital	Kharkov		Ukraine

Sponsors and Collaborators

Ursapharm Arzneimittel GmbH

Investigators

Principal Investigator: Pavel A Bezdetko, Prof., Kharkov District Clinical Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01357538

Other Study ID Numbers:

POFOBLE
S67-OPH-081
S67-OPH-081

First Posted:

May 20, 2011

Last Update Posted:

May 20, 2011

Last Verified:

May 1, 2011

Keywords provided by , ,

Additional relevant MeSH terms:

Blepharitis

Study Results

No Results Posted as of May 20, 2011