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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-06-30

Brief Summary

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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).

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Detailed Description

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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 Â± 3 Days of the global ocular discomfort evaluation (VAS).

Conditions

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Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Unifluid

Eye drops in Single Dose Unit

Group Type PLACEBO_COMPARATOR

Povidone

Intervention Type DRUG

Eye drops Single dose unit

1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.

Azithromycin

Eye drops Single dose unit

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Eye drops, Dosage : 1.5%

1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.

Interventions

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Azithromycin

Eye drops, Dosage : 1.5%

1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.

Intervention Type DRUG

Povidone

Eye drops Single dose unit

1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.

Intervention Type DRUG

Other Intervention Names

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T1225 1.5% - Azyter - Unifluid

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No