A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

A Phase 3b Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).

Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).

Key Inclusion Criteria:

• Corrected Visual Acuity (Snellen) 20/200 or better in both eyes;
• Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history;
• Capable of giving signed informed consent.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current evidence of other clinically significant ophthalmic disease other than dry eye;
• History of ocular surgery within 1 year of the Study Visit;
• Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit;
• Positive pregnancy test or currently breastfeeding.
• Other protocol-defined exclusion criteria may apply.