ISRCTN17233445.

Trial name or title	Public title: oral supplementation of omega‐3 and omega‐6 in dry eye syndrome Scientific title: a 3‐month, multicenter, double‐masked, randomized, controlled clinical study to investigate the efficacy of Medilar™ in patients suffering from dry eye syndrome
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center (2 sites) Number randomized (total and per group): 140 participants Unit of randomization (individual or eye): not reported Exclusions after randomization: not reported Losses to follow‐up: not reported Number analyzed (total and per group): not reported Unit of analysis (individual or eye): not reported Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: France and Italy Age (mean ± SD, range): not reported Gender: males and females Inclusion criteria: 1. Legally adult outpatients, both males and females 2. Having given written informed consent 3. Suffering from dry eye syndrome as defined by the presence of 3.1. At least 2 of the following 4 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 s 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. Score of at least 1, for at least 2 of the following 5 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 1 month or longer) Exclusion criteria: 1. Aged younger 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 hemorrhage 9. Drastic change in 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 intraocular inflammation within 1 month before the start 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 cyclosporine 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 child‐bearing 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 who 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 Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: 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) Intervention #2 (control): placebo (medium‐chain triglycerides), 3 capsules per day Length of follow‐up: 3 months Notes: none
Outcomes	Primary outcome(s): percentage of conjunctival epithelial cells expressing human leukocyte antigen DR‐1 (HLA‐DR) inflammatory markers in the worst eye, measured at baseline and at month 3 Secondary outcome(s): efficacy (in worst eye) at baseline, week 6, and month 3 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 [TBUT] test, Schirmer I) 4. Fluorescence intensity of conjunctival cells expressing HLA‐DR inflammatory marker 5. Quality of life questionnaire for ocular surface disease Safety outcome: adverse or unexpected events Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): not reported Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	November 22, 2005
Contact information	Prof. Catherine Creuzot‐Garcher Hôpital Général Service d'Ophtalmologie 3 Rue du Faubourg Raines BP 1519, Dijon 21034, France.
Notes	Notes: retrospectively registered Overall trial end date: January 18, 2007 Other notes: industry sponsor (Laboratoire Chauvin, Bausch & Lomb Inc., France)