Table 1.

Key inclusion and exclusion criteria assessed at baseline (day 1)

Inclusion criteriaa

• ≥18 years of age and in good general health

• OSDI score 18–65

• Use of artificial tears at least twice daily, on average, for ≥3 months prior to baseline

• Three consecutive measures of TBUT ≤10 seconds in at least one eye

• Mild to moderate corneal or conjunctival staining, as indicated by grade ≥1 (modified NEI grid) staining, related to dry eye in at least one eye

Exclusion criteria

• Schirmer’s test (with anesthesia) ≤2 mm/5 minutes in either eyeb

• Severe corneal or conjunctival staining, as indicated by grade 5 (modified NEI grid) staining, in either eyeb

• Wearing of contact lenses within 6 months prior to baseline

• Current use or use within 2 weeks of enrollment of topical ophthalmic medications such as corticosteroids, hypotensive agents, and generic cyclosporine (Restasis® [Allergan Inc., Irvine, CA, USA] was allowed if used ≥6 months prior to enrollment), or use of a systemic medication affecting dry eye

• Active ocular infection, inflammation, allergy, or blepharitis

• Abnormal corneal sensitivity, recent anterior segment surgery (eg, LASIK surgery or any surgery involving a limbal or corneal incision within 12 months of baseline visit) or trauma, anticipated or planned elective surgery during the study, or punctal occlusion

Notes:

^aSubjects with Sjogren’s disease, rheumatoid arthritis, or thyroid disease were eligible for enrollment provided they met all inclusion criteria;

^bcriteria used to identify subjects with severe dry eye.

Abbreviations: LASIK, laser-assisted in situ keratomileusis; NEI, National Eye Institute; OSDI, Ocular Surface Disease Index; TBUT, tear film break-up time.