evaluation of efficacy and safety of vismed gel multi 0.3% versus vismed multi 0.18% on treatment of ocular dryness

Conditions: Dry Eye

Summary: this study is a multicentric, comparative, randomized, investigator-blinded, parallel group study to demonstrate the non-inferiority of vismed® gel multi 0.3% in comparison with vismed® multi 0.18% in terms of cornea and conjunctiva staining (oxford score) on patients with moderate to severe ocular dryness, after 35 days of treatment.

evaluation of the non-inferiority of vismed® gel multi 0.3% in comparison with vismed® multi 0.18%, in terms of cornea and conjunctiva staining (oxford score), on worse eye, between day 0 and day 35. evaluation of the non-inferiority of vismed® gel multi 0.3% in comparison with vismed® multi 0.18%, in terms of cornea and conjunctiva staining (oxford score), on worse eye, between day 0 and day 35. * comparison of day 35 versus day 0 and day 84 versus day 0 for each product and comparison between products for the following parameters: * evolution of cornea and conjunctiva staining (oxford score) on worse eye. * evolution of deq-5 score (5-items dry eye questionnaire). * evolution of van bijsterveld score (lissamine green staining) in worse eye. * evolution of schirmer test result in worse eye. * evolution of tear film break-up time (tbut) in worse eye. * evolution of ocular dryness severity by evaluation of each main symptom by the patient and total score of all symptoms * evaluation of treatment performance by the investigator and the patient. * evaluation of the average frequency of use over 84 days for both products.

Eligibility criteria:
inclusion criteria: * sex: male or female. * age: more than 18 years. * subject with a moderate to severe dry eye syndrome needing artificial tears in the 3 months preceding the inclusion. * subject having used only artificial tears without preservative (nacl 0.9%, hydrabak®) during 1 to 2 weeks before inclusion (up to 6 times a day). * subject with a score ≥ 6 for the 5-item dry eye questionnaire (deq-5) * subject with at least one eye with: * global ocular staining (cornea and conjunctiva) ≥4 and ≤9 on the oxford scale (0 to 15) and one of the following criteria: * schirmer test ≥ 3 mm/5 min and ≤ 9 mm/5 min or * sum of 3 measurements of tear film break-up time (tbut) ≤ 30s. * subject, having given freely and expressly his/her informed consent. * subject who is able to comply with the study requirements, as defined in the present cip, at the investigator's appreciation. * in france: subject being affiliated to a health social security system. female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end. exclusion criteria: * pregnant or nursing woman or planning a pregnancy during the study. * subject deprived of freedom by administrative or legal decision. * subject in a social or health institution * subject who is under guardianship or who is not able to express his/her consent. * subject being in an exclusion period for a previous study. * subject suspected to be non-compliant according to the investigator's judgment. * subject wearing contact lenses during the study. * far best corrected visual acuity \< 1/10 * subject with severe ocular dryness with one of these conditions: * eyelid or blinking malfunction * corneal disorders not related to dry eye syndrome * ocular metaplasia * filamentous keratitis * corneal neovascularization * subject with severe meibomian gland dysfunction (mgd) * history of ocular trauma, infection or inflammation, not related to dry eye syndrome within the last 3 months prior to the inclusion. * history of ocular allergy or ocular herpes within the last 12 months. * subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months. * any troubles of the ocular surface not related to dry eye syndrome. * subject having used artificial tears in the 6 hours preceding the inclusion visit. * use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs during the month preceding the inclusion. * subjects who have received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study. * any not stabilised systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.