Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

Inclusion criteria

• Men and women aged over 18 years
• Signed and dated written informed consent
• History of dry eye syndrome for at least 3 months
• Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
• OSDI ≥ 22
• Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
• No administration of topical lubricants 24 hours before the screening examination

Exclusion criteria

• Presence of an ocular pathology judged by the investigator as incompatible with the study.
• Any other clinical relevant ocular abnormality except DES.
• History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
• History of known clinically relevant allergy.
• Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, haematological disease; severe psychiatric illness, etc.).
• History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
• Pregnancy, lactation.
• Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
• Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
• Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
• Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
• Subject is a ward of court.