Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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).
Full 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).
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
93 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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