Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye (REMOTOP)

Inclusion Criteria:

• Male or female patient between 18 and 80 years of age and in good general health condition.
• Signed written informed consent.
• Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) ≤ 10 s (mean of 3 consecutive measurements) and OSDI questionnaire ≥ 20.

Exclusion Criteria:

• Contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure.
• Concomitant or previous participation in a clinical investigation within the last 3 months.
• Concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated.
• Concurrent (systemic) DES-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change)
• Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change)
• Any diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation
• Pregnant or lactating females.
• Participants of childbearing age who do not use adequate methods of birth control.
• Subjects unable to understand the informed consent or having a high probability of noncompliance to the study procedures and/or non-completion of the study according to investigator's judgment (e.g. illiteracy, insufficient knowledge of local language).
• Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.