Efficacy and Safety Assessment of Azyter® eye drops (T1225) in patients with blepharitis

• Conditions: Patients with blepharitis

• Registration Number: EUCTR2009-017388-41-FR
• Lead Sponsor: aboratoires Théa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified