NCT01357538CompletedPhase 4
Efficacy and Safety of Posiformin 2 % Eye Ointment in the Treatment of Blepharitis - a Multi-centre, Randomised, Double-masked, Parallel-group, Phase IV Comparison
Ursapharm Arzneimittel GmbH1 site in 1 country197 target enrollmentStarted: February 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ursapharm Arzneimittel GmbH
- Enrollment
- 197
- Locations
- 1
- Primary Endpoint
- Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Posiformin 2 %
Active Comparator
Eye ointment applied to the eye lid
Intervention: Posiformin 2 %, bibrocathol (Drug)
Placebo
Placebo Comparator
corresponding vehicle, eye ointment applied to the eye lid
Intervention: Placebo Comparator (Drug)
Outcomes
Primary Outcomes
Efficacy of Posiformin 2% in reduction of signs and symptoms of blepharitis
Time Frame: 14 days
Changes from baseline in the sumscore which comprises lid edema, lid erythema, debris, pouting of Meibomian glands by slit lamp examination
Secondary Outcomes
- Changes in blepharitis signs and symptoms(14 days)
Investigators
Study Sites (1)
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