Evaluation of the efficacy and safety of unpreserved dexamethasone phosphate 0.1% eye drops (T1910) versus placebo in patients with bilateral treated severe keratoconjunctivitis sicca due to Sjögrens' syndrome

Conditions: keratoconjunctivitis sicca
MedDRA version: 8.1Level: PTClassification code 10023350Term: Keratoconjunctivitis sicca

Registration Number: EUCTR2006-003391-35-NL

Lead Sponsor: aboratoires THEA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Male or female aged from 18 to 75 years old.
2.Primary or secondary Sjögren:
ØAlready diagnosed by the rheumatologist and the maxillofacial specialist.
ØFulfilling the European criteria (Vitali et al 1996)
3.Severe dry eye syndrome in BOTH EYES defined by:
-Questioning on patient’s feeling: score = 3.
-At least two of the following ocular symptoms suggestive of dry eye: burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue, blurred vision (improved by tears substitute).
-Schirmer test < 5 mm in 5 min OR BUT < 7 s.
-Keratoconjunctivitis defined by a lissamine green score (Van Bijsterveld score) = 4

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

1.Dry eye syndrome primarily related to inflammation of ocular surface
2. Contraindications to topic dexamethasone :Glaucoma, IOP steroid responder, Herpes simplex, vaccinia, varicella zoster and most other viral infections of the cornea and conjunctiva, bacterial infections, all lesions with involvement of the corneal epithelium, Tuberculosis, fungal infections, acute purulent infections, which like other diseases caused by micro-organisms, can be masked or aggravated by the presence of steroids
3.Eyelid dysfunction : Eyelid malposition, Blepharospasm, Facial paralysis, Severe ocular progressive rosacea/ severe blepharitis
4.History WITHIN THE LAST 3 MONTHS before the inclusion visit of : Traumatism, Infection (Viral conjunctivitis / Bacterial conjunctivitis / Staphylococcal blepharitis)
5.Any relevant ocular anomaly interfering with ocular surface: chemical burns, corneal distrophy, orbital radiotherapy, etc…….
6.Known history of ocular allergy.
7. Best corrected far visual acuity (VA) = 1/10.