Dry Eye Syndromes
Conditions
Keywords
tear film, omega-3 fatty acids, eye drops
Brief summary
The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing Dry Eye Syndrome (DES) symptoms.
Interventions
DEVICEREMOGEN OMEGA
Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.
DEVICEPovidone
Artificial tears: preservative-free eye drops containing 2% povidone.
Sponsors
TRB Chemedica AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 81 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI©) questionnaire | Week 4 | — |
| Tear film stability | Week 4 | Tear film breakup time (unit: seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity (best corrected) | Day 0, Week 4, Week 12 | — |
| TearLab osmolarity test | Day 0, Week 4, Week 12 | — |
| Inflammation marker matrix metalloproteinase 9 (MMP9) | Day 0, Week 4, Week 12 | — |
| OSDI questionnaire | Day 0, Week 12 | — |
| Corneal staining | Day 0, Week 4, Week 12 | Oxford grading scale |
| Tear volume | Day 0, Week 4, Week 12 | Schirmer test |
| Conjunctival staining | Day 0, Week 4, Week 12 | Oxford grading scale |
| Lid-parallel conjunctival fold (LIPCOF) grading | Day 0, Week 4, Week 12 | — |
| Tear film stability | Day 0, Week 12 | Tear film breakup time (unit: seconds) |
Countries
Germany
Outcome results
None listed