evaluation of the efficacy and safety of dm05 versus optive™ on the treatment of moderate to severe ocular dryness

Conditions: Dry Eye

Summary: this study is a multicentric, comparative, randomized, investigator-blinded, in parallel groups study to demonstrate the non-inferiority of dm05 in comparison with optive™, 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 dm05 in comparison with optivetm, in terms of cornea and conjunctiva staining (oxford score), on worse eye, between d0 and d35. * comparison of d35 versus d0 and d84 versus d0 for each product and comparison between products for the following parameters: * evolution of cornea and conjunctiva staining (oxford score) on worse eye. * evolution of osdi score (ocular surface disease index). * 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 during 84 days for dm05 and optivetm. selection visit: d-14 to d-7 wash-out period: 1 to 2 weeks with preservative-free 0.9% nacl at 3 drops per day (hydrabak®): d0 : inclusion visit follow-up visits: d35, d84

Eligibility criteria:
inclusion criteria: * sex: male or female. * age: more than 18 years. * subject with a 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 or 2 weeks before inclusion (at 3 drops per day). * diagnosis of moderate to severe ocular dryness defined by a score osdi (ocular surface disease index) ≥18. * subject with at least one eye with: * global ocular staining (cornea and conjunctiva) ≥4 and ≤9 (oxford scale from 0 to 15) and one the following criteria: * schirmer test ≥ 3mm/5 min and ≤9mm/ 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 protocol, 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 sanitary establishment. * major subject who is under guardianship or who is not able to express his 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) * within the last 3 months prior to the inclusion, history of ocular trauma, infection or inflammation not related to dry eye syndrome. * within the last 12 months, history of ocular allergy or ocular herpes. * refractive or cataract surgery within the last 6 months. * any laser other than refractive surgery within the last 3 months. * any troubles of the ocular surface not related to dry eye syndrome. * ocular hypertension or glaucoma needing an hypotonic treatment * subject having used artificial tears in the 6 hours preceding the inclusion visit. * use during the month preceding the inclusion or during the study of: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs. * any not stabilized systemic treatment, which can have an effect on performance or safety criteria, at the investigator appreciation.