Study of Safety and Performance of a Novel Ocular Lubricant in Subjects With Dry Eye Disease

A Single-Arm Study to Evaluate and Demonstrate Safety and Performance of a Novel Ocular Lubricant in Adult Subjects With Dry Eye Disease

The purpose of this study is to evaluate and demonstrate the efficacy and safety of an investigational ocular lubricant formulation in patients with mild to moderate dry eye disease (DED).

The study will consist of a Screening visit, a Baseline visit on Day 1, a remote Compliance Check on Day 14, and an Exit visit on Day 30. The expected study duration of participation for each subject is 37 days, with 30 ± 5 days of exposure to the investigational product.

Key Inclusion Criteria:

• Willing and able to understand and sign an approved informed consent form.
• Exhibit symptoms of dry eye at the Screening visit.
• Best Corrected Visual Acuity equal to or better than 20/80 Snellen in each eye at the Screening visit.
• Willing to discontinue use of all artificial tear supplements and use only the study product as directed starting at Visit 2/Day 1.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Pregnant, breastfeeding, or planning to become pregnant during the study.
• Ocular abnormalities that could adversely affect the safety or efficacy outcome.
• Uncontrolled active systemic diseases.
• Use of systemic medications known to cause dry eye.
• Other protocol-defined exclusion criteria may apply.