NCT03460548.

Trial name or title	Public title: Remogen® Omega versus Cationorm® in the treatment of patients suffering from dry eye Scientific title: a multicentre randomized trial comparing the efficacy and safety of Remogen® omega versus Cationorm® in the treatment of patients suffering from dry eye
Methods	Study design: randomized, parallel‐group, controlled trial Study site(s): multi‐center Number randomized (total and per group): 96 participants (planned) 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 Age (mean ± SD, range): 18 years and older (planned) Gender: both (planned) Inclusion criteria: at least a 3‐month documented history of bilateral dry eye; a score of ocular surface staining with fluorescein ≥ 4 and ≤ 9 on the Oxford scale; at least one objective sign of tear deficiency; OSDI score of ≥ 18 Exclusion criteria: refractive surgery within 12 months prior to selection; any other ocular surgery or ocular trauma within 6 months prior to selection; systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: Remogen 4 times daily Intervention #2 (control): Cationorm 4 times daily Length of follow‐up: 28 days Notes: none
Outcomes	Primary outcome(s): fluorescein staining Secondary outcome(s): not listed Adverse events reported? (Y/N): not reported Measurement time points (specify intervals at which outcomes were assessed): 28 days Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	April 9, 2018
Contact information	Dr. Sabine Collaud Basset Quinze‐Vingts Hospital, Paris, France
Notes	Recruitment status: recruiting Actual completion date: December 2019 (estimated) Last update posted: April 10, 2019

BODI: Brief Ocular Discomfort Index; DEQ: Dry Eye Questionnaire; DES: Dry eye syndrome; DHA: docosahexaenoic acid; EPA: eicosapentaenoic acid; HLA‐DR: human leukocyte antigen‐DR; ICD: implantable cardioverter‐defibrillator; IDEEL: Impact of Dry Eye on Everyday Life; IOP: intraocular pressure; IRB: institutional review board; LASIK: laser‐assisted in situ keratomileusis; MMP‐9: matrix metalloproteinase‐9; MUC: mucin; NSAID: non‐steroidal anti‐inflammatory drug; OCI: Ocular Comfort Index; OSDI: Ocular Surface Disease Index; PRK: photorefractive keratectomy; SD: standard deviation; SESOD: Subjective Evaluation of Symptom of Dryness; SPEED: Standard Patient Evaluation of Eye Dryness; TBUT: tear break‐up time; WHS: Women's Health Study.