NCT01357538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
Last Updated

May 20, 2011

Status Verified

May 1, 2011

Enrollment Period

5 months

First QC Date

May 18, 2011

Last Update Submit

May 19, 2011

Conditions

BlepharitisSigns and Symptoms

Keywords

Bibrocatholeye ointmentblepharitiseye lid

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in blepharitis signs and symptoms

    14 days

Study Arms (2)

Posiformin 2 %

ACTIVE COMPARATOR

Eye ointment applied to the eye lid

Drug: Posiformin 2 %, bibrocathol

Placebo

PLACEBO COMPARATOR

corresponding vehicle, eye ointment applied to the eye lid

Drug: Placebo Comparator

Interventions

Posiformin 2 %, bibrocatholDRUG

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

Posiformin 2 %
Placebo ComparatorDRUG

corresponding vehicle, eye ointment applied to the eye lid

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • different ocular conditions
  • different system conditions
  • several concomitant medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kharkov District Clinical Hospital

Kharkiv, Ukraine

Location

Related Publications (1)

  • Bezdetko PA, Sergienko N, Dyomin Y, Korol A, Nikitin N, Merzbacher M, Gross D, Kohnen R. Successful treatment of blepharitis with bibrocathol (Posiformin(R) 2 %). Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1869-75. doi: 10.1007/s00417-012-2001-0. Epub 2012 Apr 25.

    PMID: 22527308DERIVED

MeSH Terms

Conditions

BlepharitisSigns and Symptoms

Interventions

bibrocathol

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesPathological Conditions, Signs and Symptoms

Study Officials

  • Pavel A Bezdetko, Prof.

    Kharkov District Clinical Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 20, 2011

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

May 20, 2011

Record last verified: 2011-05

Locations

UA(1)