a study to evaluate the performance and safety of artelac rebalance® versus vismed in the management of dry eye

Conditions: Dry Eye

Summary: the objective of this investigation is to show that the performance of artelac rebalance eye drops is non-inferior to that of vismed eye drops in subjects with moderate to severe dry eye, and to assess the safety of artelac rebalance after a 90-day (± 10 day) treatment administered 3 to 5 times per day.

artelac rebalance and vismed are in compliance with european directives (ce marked) products in the european union (eu).

Eligibility criteria:
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