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

Ursapharm

Status and phase: Completed; Phase 4

Conditions: Blepharitis; Signs and Symptoms

Treatments: Drug: Placebo Comparator; Drug: Posiformin 2 %, bibrocathol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01357538

S67-OPH-081

POFOBLE

Details and patient eligibility

About

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.

Full description

Reduction of signs and symptoms of blepharitis

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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197 participants in 2 patient groups, including a placebo group

Posiformin 2 %

Active Comparator group

Description:

Eye ointment applied to the eye lid

Treatment:

Drug: Posiformin 2 %, bibrocathol

Placebo

Placebo Comparator group

Description:

corresponding vehicle, eye ointment applied to the eye lid

Treatment:

Drug: Placebo Comparator