Table 1.

Major Patient Selection Criteria

Inclusion ≥18 years of age Reported history of dry eye and had used or desired to use eye drops to treat the condition for ≥6 months before the first treatment visit On treatment visits 1 and 2 patients had to have ○ BCVA of ≥0.7 logMAR (Snellen equivalent score of ≥20/100) ○ Score of ≥2 on the Ora Calibra® Ocular Discomfort and 4-Symptom Questionnaire in ≥1 of the dry eye symptoms ○ Schirmer's test score of ≤10 and ≥1 mma ○ Corneal fluorescein staining score of ≥2 in any corneal region (inferior, central, or superior) according to the Ora Calibra Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in ≥1 eyea ○ Conjunctival redness score ≥1 according to the Ora Calibra Conjunctival Redness for Dry Eye Scale in ≥1 eye (2-week visit pre-CAE)a Demonstrated response to CAE at baseline and 2-week visit in the same eye(s)a ○ ≥1 point increase in fluorescein staining in the inferior region in ≥1 eye after CAE exposure ○ Ocular Discomfort score ≥3 at ≥2 time points in ≥1 eye during CAE exposure Exclusion Clinically significant slit-lamp findings at screening, including active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that required therapeutic treatment or would interfere with study Been diagnosed with an ongoing ocular infection or active ocular inflammation Worn contact lenses within 7 days of screening or planned to wear LASIK surgery performed within 12 months, ocular and/or lid surgeries in past 6 months or planned during the study Laser procedures in the previous 3 months Use of cyclosporine or lifitegrast ophthalmic solutions within 60 days of screening Use of or anticipated use of temporary punctal plugs during study that were not stable within 30 days of screening Unable to discontinue topical ophthalmic prescriptions for the duration of the trial

^a At least 1 eye (same eye) had to satisfy all these criteria.

BCVA, best-corrected visual acuity; CAE, controlled adverse environment; logMAR, logarithm of the minimum angle of resolution.