Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

Inclusion Criteria:

• Documented history of dry eyes for at least 3 months.
• Ocular discomfort due to dry eyes.
• Presence of corneal and conjunctival staining.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women who are pregnant or lactating.
• Contact lens wear within 1 week before Screening and during the study.
• Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
• Punctal plugs or punctal occlusion initiated within 3 months of screening
• Other protocol-defined exclusion criteria may apply.