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

Exclusion Criteria

• •Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
• •Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• •Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
• •Eye drop use within 2 hours of Visit 1;
• •Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• •Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days 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 surgery within 6 months of Visit 1;
• •Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1