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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Compa

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 Summary:

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).


Sponsor: Laboratoires Thea

Current Primary Outcome: Visual Analogue Scale (VAS - Ranges 0-100 mm) [ Time Frame: 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)


Original Primary Outcome: Visual analogue scale [ Time Frame: D0 and D63 ]

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)


Current Secondary Outcome:

Original Secondary Outcome: VAS and ocular tolerance [ Time Frame: VAS : D7, D28 D57. Ocular tolerance : D7, D28, D57 and D63 ]

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 blepharitis, 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.



Information By: Laboratoires Thea

Dates:
Date Received: March 17, 2010
Date Started: March 2010
Date Completion:
Last Updated: November 3, 2014
Last Verified: October 2014