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

TRB Chemedica

Status

Completed

Conditions

Dry Eye Syndromes

Treatments

Device: Povidone

Device: REMOGEN OMEGA

Study type

Interventional

Funder types

Industry

Identifiers

REMODES-DE-2015-12

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.

Enrollment

81 patients

Sex

All

Ages

18 to 81 years old

Volunteers

No Healthy Volunteers

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.