Medical Affairs Director

CONTACT

Lead Sponsor

Laboratoires Thea

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Men and women aged over 18 years,
•Able to give written informed consent prior the initiation of any procedure,
•History of dry eye syndrome for at least 3 months,
•OSDI ≥13,
•Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears.

•Known or suspected hypersensitivity to one of the components of the IMD,
•History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment.
•Pregnant or breast-feeding women,
•Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) .
•Alcohol addiction and heavy smoker according to investigator's judgement,
•Unable to understand the investigation procedures or to give informed consent,
•Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance),
•Participant in this investigation at the same time as another clinical investigation/study,
•Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month,
•Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company.
•Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).