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

aboratoires Théa0 个研究点目标入组 80 人开始时间: 2009年12月8日最近更新: 2012年3月19日

试验速览

暂无简介。

•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
•-a severity score =2 for either eyelid secretions or plugging of the MG (or both)
•-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.
•-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

•-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.

发起方

aboratoires Théa