Idroflog® for Treatment of Dry Eye Disease (IDROFLOG)

This study aims at demonstrating the non-inferiority of Idroflog compared to sodium hyaluronate 0.18% for the disease improvement of people with documented history of dry eyes and use of tear substitutes for at least 3 months.

Inclusion Criteria:Provision of signed and dated informed consent formStated willingness to comply with all study procedures and availability for the duration of the studyAged ≥ 18 yearsDocumented history of dry eyes and use of tear substitutes for at least 3 months within the last yearPresence of corneal fluorescein staining (Oxford Scale, Score ≥ 2) in at least one eyeOcular Surface Disease Index (OSDI) ≥ 23Reduced tear break-up time (< 11 seconds)Exclusion Criteria:Women who are pregnant or lactatingBest far corrected visual acuity < 1/10 in both eyesKnown hypersensitivity to one of the components of the study medications or test productsUse of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study periodOcular surgery (of any type, including laser surgery and punctal plugs) or ocular trauma within the 4 months prior to screeningActive ocular infectionActive allergies requiring treatmentGlaucoma