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

A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Two Concentrations (0.10%, 0.25%) of HL036 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye

The objective of this study was to compare the safety and efficacy of 0.10% and 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 enrollment
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
• Have in the study eye 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 used Restasis® or Xiidra® within 60 days of Visit 1
• Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
• Have an uncontrolled systemic disease
• Be a woman who is pregnant, nursing or planning a pregnancy