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Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

2010-07-15 17:00:00 | BioPortfolio

Summary

The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).

Description

Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.

Patients will be treated for 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.

Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Blepharitis

Intervention

Azithromycin (T1225/Azyter), Povidone

Location

Hôpital Gabriel Montpied
Clermont-Ferrand
France
63003

Status

Not yet recruiting

Source

Laboratoires Thea

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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