The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

Inclusion Criteria:

• 18 years of age (either gender and any race);

• Reported history of dry eye for at least 6 months prior to Visit 1;

• Reported history of use or desire to use eye drops for dry eye symptoms within 6months of Visit 1

Exclusion Criteria:

• Clinically significant slit lamp findings at Visit 1 that may include activeblepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or activeocular allergies that require therapeutic treatment, and/or in the opinion of theinvestigator may interfere with study parameters;

• Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or activeocular inflammation at Visit 1;

• Contact lens use within 7 days of Visit 1 or anticipate using contact lenses duringthe trial;

• Eye drop use within 2 hours of Visit 1;

• Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12months;

• Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90days of Visit 1;

• Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids)within 14 days of Visit 1 or anticipate such therapy throughout the study period;

• Planned ocular and/or lid surgeries over the study period or any ocular surgerywithin 6 months of Visit 1;

• Temporary punctal plugs during the study that have not been stable within 30 days ofVisit 1