NCT02871440.

Trial name or title	Public title: a two comparator, controlled phase 3 study in patients with and without evaporative dry eye Scientific title: a two comparator, controlled phase 3 Study of OM3 tear formulation versus OPTIVE ADVANCED unit dose and OPTIVE unit dose eye drops in patients with and without evaporative dry eye
Methods	Study design: randomized, cross‐over, controlled trial Study site(s): not reported Number randomized (total and per group): 57 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: Australia Age (mean ± SD, range): not reported Gender: both sexes eligible to participate Inclusion criteria: 1. Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent 2. Over 18 years of age 3. Not wearing contact lenses in the past 3 months before enrolling 4. Willing to use eye drops and comply with the study visit schedule as directed by the investigator 5. Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye 6. At the screening visit (day ‐14), patients must have Ocular Surface Disease Index (OSDI) score > 18 (0 to 100 scale). At baseline (day 1) visits, patients must have OSDI score > 12 to continue in the study 8. TBUT≤ 10 s in at least 1 eye at screening visit and at baseline visit 9. Corneal fluorescein staining score ≥ 1 and < 4 (Oxford scheme) at screening and baseline visits Exclusion criteria: 1. Schirmer test (with anesthesia) ≤ 2 mm in either eye at screening 2. Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the screening visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use at the screening visit 3. Any active anterior segment disease excluding blepharitis 4. Any systemic disease that may affect ocular health (eg, Graves' disease, autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, and systemic lupus erythematosus) 5. History of epilepsy or migraines exacerbated by flashing, strobe‐like lights 6. Rigid or soft contact lens wearer, including orthokeratology 7. History of eye surgery within 6 months before enrollment in the study 8. Previous corneal refractive surgery Equivalence of baseline characteristics? (Y/N): not reported
Interventions	Intervention #1: omega‐3 eye drop Intervention #2: Optive Advanced eye drop Intervention #3: Optive eye drop Length of follow‐up: 4 weeks Notes: topical omega‐3 intervention
Outcomes	Primary outcome(s): tear evaporation rate, measured by a vapometer (g ‐ 2 h) Secondary outcome(s): TBUT and subjective ocular comfort (measured using visual analogue scales from 0 to 100) Adverse events reported? (Y/N): N Measurement time points (specify intervals at which outcomes were assessed): baseline, up to 4 weeks Other issues with outcome assessment (eg, quality control for outcomes, if any): none
Starting date	September 19, 2016
Contact information	Jacqueline Tan‐Showyin The University of New South Wales, Australia
Notes	Actual study completion date: September 18, 2017 Last update posted: August 2, 2018 Other notes: single‐masked (investigator only) Study undertaken in collaboration with Allergan (industry)