Title
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
Phase
Phase 2Lead Sponsor
Laboratoires TheaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
BlepharitisIntervention/Treatment
azithromycin povidone-iodine ...Study Participants
93The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
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).
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.
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.
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.
| Event Type | Organ System | Event Term |
|---|
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)
