Patients with blepharitis
Conditions
Interventions
Trade Name: Azithromycin dihydrate
Product Name: AZYTER
Product Code: T1225 1.5%
Pharmaceutical Form: Eye drops, solution
CAS Number: 117772700
Current Sponsor code: T1225 1.5%
Other descriptive name:
Sponsors
Laboratoires Théa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye defined by: -a severity score =2 for either redness or swelling (or both) of the eyelid margin AND -a severity score =2 for either eyelid secretions or plugging of the MG (or both) AND -a severity score =2 for at least 2 symptoms among the following : irritation, burning, itching, tearing, crusting eyelashes, eyelid sticking, light sensitivity, increased frequency of blinking. AND -a Global Ocular Discomfort by VAS > 35 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Monophtalmia -Eyelid dysfunction: Eyelid malposition, eyelash malposition, ectropion, entropion, malocclusion.Blepharospasm,Facial paralysis. -Severe dry eye syndrome defined by at least one of the following criteria : Total cornea fluorescein staining score = 4 (NEI scale, using a five-zone system with 0-3 grades in each zone) and with at least one area of grade 2 in one zone in the same eye. - Ocular metaplasia. - Filamentous keratitis -Schirmer test < 5 mm. -Best far corrected visual acuity = 1/10. -History of Inflammatory ocular disease such as : uveitis, recidivant herpetic keratitis, atopic keratoconjunctivitis, Steven-Johnson Syndrome, Scare pemphigoid, -History WITHIN THE LAST 3 MONTHS before the inclusion visit of : Traumatism, Infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort ( (VAS) in patient with blepharitis after 3 monthly treatment periods of 7 days (1 drop twice daily the first day, following by one drop once daily for 6 days).;Secondary Objective: The secondary clinical efficacy objectives are as follow: •Global (subjective and objective) VAS = [Discomfort VAS + [(redness + swelling + MGD+ )VAS / 3] ] / 2 •To compare the efficacy of T1225 eye drops versus placebo with respect of the assessment of the patient’s symptomatology evaluation (VAS) after 7 days, 28 days and 57 days of study period, the ocular symptoms suggestive of blephatitis, the objective ocular signs (slit lamp examination, corneal stained punctuations, BUT values 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. ;Primary end point(s): 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). | — |
Countries
France
Outcome results
None listed