A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye

Date de début de l'étude : 1 mai 2013

Inclusion Criteria: Subjects who have been using tear substitutes for at least 3 months prior to inclusion, and who will use preservative-free ART (Artelac® UNO CL hypromellose 0.32% w/v eye drops, single dose unit) up to 6 times a day for at least 2 weeks immediately prior to randomization Subjects with at least 1 eye with the following signs of keratoconjunctivitis sicca at 2 consecutive visits (Visit 1[Screening] and Visit 2 [Randomization]) Schirmer test without anesthesia of ≤ 9 mm/5min Tear break-up time of ≤ 10sec (mean of 3 measurements) Total ocular surface staining score ≥ 4 and ≤ 9. This assessment combines corneal fluorescein staining and nasal and temporal bulbar conjunctival lissamine green staining, each graded 0-5 according to the Oxford Scheme Subjects who have a decimal visual acuity (VA) with habitual correction equal to or better than 0.1 (Snellen E chart) in both eyes Subjects who are receiving stable systemic treatment (unchanged for 1 month or longer) Exclusion Criteria: Subjects with moderate or severe blepharitis Subjects who have severe ocular dryness accompanied by 1 of the following: Lid abnormality (except mild blepharitis) Corneal disease Ocular surface metaplasia Filamentary keratitis Corneal neovascularization Subjects who currently wear contact lenses or have worn contact lenses within 90 days prior to study start Subjects who have received ocular surgery, including laser surgery, in either eye within 180 days prior to study start Subjects with a history of ocular trauma, non-dry eye ocular inflammation, or ocular infection within 90 days prior to study start Subjects with a history of ocular allergic disease or ocular herpes within 1 year prior to study start Subjects with a history of any inflammatory ulcerative keratitis, recurrent corneal erosion, or uveitis Subjects with known hypersensitivity or contraindications to any of the ingredients in the test or comparator products Subjects with planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of Visit 1 (Screening) or during the study Subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start Subjects expected to receive ocular therapy during the study Subjects treated with topical ocular steroidal or non-steroidal anti- inflammatory medication within 30 days prior to study start Subjects expected to receive ocular therapy with immunosuppressants (eg, cyclosporine) during the study or who have used ocular immunosuppressants within 90 days prior to study start Subjects who have received occlusion therapy with lacrimal or punctum plugs within 90 days prior to study start