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

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: REMOGEN OMEGA
* Device: Povidone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PUFA (polyunsaturated fatty acids)-group<br>REMOGEN OMEGA: Usage according to instructions for use. | Device: REMOGEN OMEGA<br>* Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.<br>|
| Other: C (control)-group<br>Povidone: Usage according to instructions for use. | Device: Povidone<br>* Artificial tears: preservative-free eye drops containing 2% povidone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI©) questionnaire |  | Week 4 | 
| Tear film stability | Tear film breakup time (unit: seconds) | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSDI questionnaire |  | Day 0, Week 12 | 
| Tear film stability | Tear film breakup time (unit: seconds) | Day 0, Week 12 | 
| 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 | 
| Lid-parallel conjunctival fold (LIPCOF) grading |  | Day 0, Week 4, Week 12 | 
| Corneal staining | Oxford grading scale | Day 0, Week 4, Week 12 | 
| Tear volume | Schirmer test | Day 0, Week 4, Week 12 | 
| Conjunctival staining | Oxford grading scale | Day 0, Week 4, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tear film, omega-3 fatty acids, eye drops