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

Phase 2

Completed

• Conditions: Blepharitis
• Interventions: Drug: Povidone; Drug: Azithromycin

• Registration Number: NCT01089608
• Lead Sponsor: Laboratoires Thea

Brief 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).

Detailed 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 during 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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-10
• Results First Submitted: 2014-10-07
• Results First Submitted QC: 2014-11-03
• Last Update Submitted: 2014-11-03
• Results First Posted: 2014-11-04
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

Exclusion Criteria

• Monophtalmia
• Eyelid dysfunction
• Facial paralysis.
• Severe dry eye syndrome.
• Ocular metaplasia.
• Filamentous keratitis
• Schirmer test < 5 mm.
• Best far corrected visual acuity < 1/10.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unifluid	Povidone	Eye drops in Single Dose Unit
Azithromycin	Azithromycin	Eye drops Single dose unit

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS - Ranges 0-100 mm)	Baseline and D63 (D63 minus baseline)	The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)

Trial Locations

Locations (1)

C.H.N.O des XV-XX; 🇫🇷 Paris, France