The purpose of this study is to evaluate the efficacy and safety of rebamipide ophthalmic suspension in subjects with dry eye syndrome.

Inclusion Criteria:

• History of dry eye-related ocular symptoms for at least 20 months.
• Meet protocol-defined criteria for corneal and conjunctival staining.
• Meet protocol-defined criteria for ocular discomfort.

Exclusion Criteria:

• Active anterior segment ocular disease other than dry eye syndrome.
• Inability to suspend the use of topical ophthalmic medications throughout the duration of the study.
• Inability to suspend the use of contact lenses for the duration of the study.
• Judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease, or safety concerns.
• Received any other investigational product within 4 months before the screening visit.