Dry eye syndrome Eye Diseases Disorders of lacrimal system
Conditions
Interventions
Test product - Medilar™:
Oral supplementation with 855 mg of omega-3 and 15 mg of omega-6, vitamins (C,E, B6, B12) and zinc per day (3 capsules per day) for 3 months.
Comparator:
Placebo (medium ch
Sponsors
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Legally adult outpatients, both males and females 2. Having given their written informed consent 3. Suffering from dry eye syndrome as defined by the presence of: 3.1. At least two of the following four objective tests corresponding to the scores below: 3.1.1. Schirmer-I-values less than 10 mm/5 min 3.1.2. Break-up-time-values less than 10 sec 3.1.3. Fluorescein staining of the cornea score greater than or equal to 1 and less than 4 3.1.5. Van Bijsterveld score greater than or equal to 3 and less than or equal to 6 (Lissamine green) 3.2. A score of at least 1, for at least two of the five following subjective tests (scored 0 to 3): 3.2.1. Foreign body sensation 3.2.2. Dryness 3.2.3. Burning 3.2.4. Stinging 3.2.5. Photophobia 4. Stable systemic treatment (unchanged for one month or longer)
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 years 2. Severe dry eye (Lissamine green greater than 6 or corneal staining greater than or equal to 4) 3. Uncontrolled evolutive systemic disease 4. Patients with an implantable cardioverter defibrillator (ICD) 5. Uncontrolled inflammatory disease (treated with varying doses of steroids or non-steroidal anti-inflammatory substances) 6. Change in systemic treatment within the last month 7. Expected change in treatment of concomitant disease 8. Patients treated with anticoagulants or predisposed to bleeding or haemorrhage 9. Drastic change of food and/or food supplements within the last month 10. Other food supplement with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) 11. Patients with a history of recurrent ocular herpes and/or recurrent uveitis 12. Evidence of acute ocular infection and/or intra-ocular inflammation within one month prior to the onset of this study 13. Patients who have undergone ocular surgery within the last 6 months 14. Change in ocular treatment within the last month 15. Patients currently using any ophthalmic medication including any ocular ointment except artificial tear preparation and eye cleaning solution for treatment of dry eye syndrome 16. Patients treated with topical ocular, steroidal or non-steroidal anti-inflammatory treatment within the last month 17. Patients treated with ocular topical cyclosporin within the last month 18. Occlusion therapy with lacrimal or punctum plugs within the last 3 months 19. Patients currently wearing contact lenses 20. Pregnant or lactating women 21. Women of childbearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy 22. Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study 23. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow-up in the study period 24. Known contraindication, adverse reaction, or hypersensitivity to any constituents of this food supplement 25. Patients who have participated in any clinical investigation within the last 30 days or are currently participating in a clinical study 26. Patients who are addicted to alcohol or drugs 27. Patients with neurotic, psychiatric disorders or suicidal tendencies 28. Patients who plan to start a diet or to change their diet during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of conjunctival epithelial cells expressing human leukocyte antigen DR-1 (HLA-DR) inflammatory markers in the worst eye, measured at baseline and month 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (in worst eye): 1. Global subjective dry eye score (foreign body sensation, dryness, burning, stinging, photophobia) 2. Subjective dry eye score for each symptom 3. Objective dry eye score for each test (fluorescein staining of the cornea, Van Bijsterveld test, tear Break-Up Time [BUT] test, Schirmer-I) 4. Fluorescence intensity of conjunctival cells expressing HLA-DR inflammatory marker 5. Quality of life questionnaire for ocular surface disease Safety: 6. Adverse or unexpected events All secondary outcomes were assessed at baseline (D0), week 6 and month 3. | — |
Countries
France, Italy
Outcome results
None listed