A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of 0.25% HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Inclusion Criteria:

• Have a patient-reported history of dry eye for at least 6 months prior to Visit 1
• Be willing and able to comply with all study procedures
• Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

Exclusion Criteria:

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
• Have any previous experience using HL036