keratoconjunctivitis sicca MedDRA version: 8.1 Level: PT Classification code 10023350 Term: Keratoconjunctivitis sicca
Conditions
Interventions
Trade Name: Monofree Dexamethason 1mg/ml
Pharmaceutical Form: Eye drops*
INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE
CAS Number: 2392394
Concentration unit: % percent
Concentration type: equa
Sponsors
Laboratoires THEA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the efficacy of unpreserved Dexamethasone Phosphate 0.1% eye drops versus placebo in patients with bilateral severe keratoconjunctivitis sicca due to primary or secondary Sjögren syndrom.;Secondary Objective: ;Primary end point(s): Primary efficacy criteria: 1.Symptomatology within the last 48 hours: evaluation on a Visual analogue scale (Day 7). Secondary efficacy criteria: 1.Symptomatology within the last 48 hours: evaluation on a Visual analogue scale (Day 35). 2.Patient’s feeling assessment. 3.Ocular symptoms suggestive of dry eye within the last 48 hours. §Schirmer test without anaesthesia. §Slit lamp examination: After fluorescein administration by a blue light beam: BUT and Oxford scheme. By a white light beam: Blepharitis (including meibomitis), Conjunctival hyperaemia, Conjunctival discharge, Chemosis, Folliculo-papillary conjunctivitis, filamentary keratitis, other clinically relevant signs. After lissamine green administration: Van Bijsterveld score. §Assessments of the efficacy for right and left eye by the investigator. §Number of drop out patients due to lack of efficacy §Change in ocular concomitant artificial tears. | — |
Countries
Netherlands
Outcome results
None listed