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

• Visual analogue scale [ Time Frame: D0 and D63 ] [ Designated as safety issue: No ]
  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)
  
  

• VAS and ocular tolerance [ Time Frame: VAS : D7, D28 D57. Ocular tolerance : D7, D28, D57 and D63 ] [ Designated as safety issue: Yes ]

  Global Discomfort VAS + [(Redness of eyelid margin + Swelling of eyelid + Meibomian gland dysfunction + Quality of MG secretion)VAS / 4] ] / 2 To compare the efficacy of T1225 eye drops versus placebo with respect of the assessment of the patient's symptomatology evaluation, the ocular symptoms suggestive of blephatitis, the objective ocular signs ( and the global efficacy assessment by the investigator.

  To compare the ocular tolerance of T1225 eye drops versus placebo with respect of the assessment of the global local tolerance assessment by the investigator and by the patient.

  
  

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).