This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.

Inclusion Criteria:

• History of artificial tear use
• Moderate to severe signs of dry eye
• Moderate to severe ocular discomfort

Exclusion Criteria:

• Patients with uncontrolled systemic or ocular diseases.
• Have any history of refractive surgery
• Use any topical ocular medications other than those dispensed for the study, during the study

Other protocol-defined exclusion criteria may apply.