Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

Exclusion Criteria

• •clinically significant blepharitis or Meibomian Gland Dysfunction (MGD) or lid margin inflammation, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
• •diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis), or preauricular lymphadenopathy, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
• •Reported an ocular discomfort score of 4+ in both eyes at time 0 of CAE exposure at Visits 2 or 3
• •Wore contact lenses and refused to remove them for the duration of the study
• •previous laser in situ keratomileusis (LASIK) surgery
• •currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and could not discontinue these medications for the duration of the study
• •presently taking any medication known to cause ocular drying that had not been a stable dose for at least 30 days
• •currently taking oral antihistamines that could not be discontinued during the study
• •a systemic disease, uncontrolled medical condition that in the opinion of the investigator could interfere with study measurements or subject compliance
• •received another experimental drug or device within 30 days prior to screening