A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease

Inclusion Criteria:

• Eighteen to 70 years of age at the time of screening (either gender and any race)

• Ability to provide written informed consent

• Reported history of ocular discomfort associated with dry eye disease for at least 6months prior to Visit 1

• Reported history of the use of eye drops for dry eye disease between 2 weeks to 6months prior to Visit 1

Exclusion Criteria:

• Clinically significant slit lamp findings, intraocular pressure, and visual acuityfindings at Visit 2 that may include active blepharitis, severe meibomian glanddysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or anyother disorder that, in the opinion of the Investigator, may interfere with trialconduct or assessments

• Diagnosis at Visit 1 of an ongoing ocular infection (bacterial, viral, or fungal),active ocular inflammation, or history of inflammatory disease that, in the opinionof the Investigator, could interfere with trial conduct or assessments

• Contact lens use within 7 days of Visit 1 or anticipated use of contact lensesduring the trial

• Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1and/or planned ocular and/or lid surgeries during the trial or any other ocularsurgery within 6 months of Visit 1

• Systemic corticosteroid or other immunomodulatory therapy (not including inhaledcorticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapyduring the trial

• Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue anytopical ophthalmic prescription or over-the-counter solutions, artificial tears,gels, or scrubs for the duration of the trial (excluding medications allowed for theconduct of the trial)