NCT00357201.

Trial name or title	Evaluation of the efficacy of T1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation versus placebo in patients with bilateral treated moderate dry eye syndrome
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): single‐center Number randomized (total and per group): not reported 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): individual (right eye) Reported power calculation? (Y/N): N Reported subgroup analysis? (Y/N): N
Participants	Participant characteristics Country: France Age (mean ± SD, range): not reported Gender: not reported Inclusion criteria: 1. Signed and dated informed consent 2. Male or female from 18 to 90 years old 3. Known treated bilateral dry eye 4. Dry eye syndrome confirmed by ocular examination with fluorescein and/or lissamine green staining, TBUT, and Schirmer, performed within the last 12 months before the inclusion visit, for both eyes 5. Bilateral symptoms suggestive of dry eye defined by at least 1 of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and questioning on patient’s feeling (score ≥ 3) 6. Fulfilling the following criteria of dry eye syndrome in both eyes defined by keratoconjunctivitis defined by a lissamine green score ≥ 4 (van Bijsterveld score) and Schirmer test ≤ 10 mm in 5 min or TBUT < 10 s Exclusion criteria: 1. Severe dry eye symptoms 2. Eyelid dysfunction 3. Severe progressive rosacea 4. Any relevant ocular anomaly interfering with ocular surface 5. Best‐corrected far visual acuity ≤ 1/10 6. History of ocular allergy 7. Trauma, infection, inflammation within last 3 months 8. Ocular surgery and laser within last 3 months 9. LASIK, laser, PRK within last 12 months 10. Contact lenses 11. Any concomitant nutritive supplementation, vitamins 12. Any topical concomitant treatment Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: omega‐3 and omega‐6 polyunsaturated essential fatty acid (T1675) supplements Intervention #2 (control): placebo supplements Length of follow‐up: 6 months Notes: none
Outcomes	Primary outcome(s): total score of lissamine green staining in the right eye Secondary outcome(s): global efficacy; tolerance Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, months 1, 3, 12, 18, 24, 30, and 36 Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	November 2004
Contact information	Dr. Catherine Creuzot‐Garcher CHU of Dijon, France
Notes	Recruitment status: completed (May 2005) Last post updated: October 2006