A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye

Inclusion criteria

• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
• Over 18 years of age;
• Not wearing contact lenses in the past 3 months before enrolling
• Willing to use eye drops and comply with the study visit schedule as directed by the Investigator;
• Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye;
• 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.
• TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit
• Corneal sodium fluorescein staining score ≥ 1 and <4 (Oxford scheme) at Screening and Baseline visit.

Exclusion criteria

• Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening
• 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;
• Any active anterior segment disease excluding blepharitis;
• Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
• History of epilepsy or migraines exacerbated by flashing, strobe-like lights;
• Rigid or soft contact lens wearer, including orthokeratology;
• History of eye surgery within 6 months prior to enrolment in the study;
• Previous corneal refractive surgery