Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis
Phase 4
Completed
- Conditions
- BlepharitisSigns and Symptoms
- Interventions
- Drug: Placebo Comparator
- Registration Number
- NCT01357538
- Lead Sponsor
- Ursapharm Arzneimittel GmbH
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Posiformin 2 % Posiformin 2 %, bibrocathol Eye ointment applied to the eye lid Placebo Placebo Comparator corresponding vehicle, eye ointment applied to the eye lid
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Kharkov District Clinical Hospital
🇺🇦Kharkov, Ukraine