A Study of TL-925 as a Treatment for Dry Eye Disease

A Phase 2, Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety and Tolerability of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease

In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

Inclusion Criteria:

• Individuals aged 18 years or older
• A diagnosis of dry eye disease for at least 6 months
• An unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eye
• A tear film break-up time (TFBUT) of ≤ 5 seconds in the study eye
• A corneal fluorescein staining score of ≥ 2 in at least one region of the cornea
• A sum corneal fluorescein staining score of ≥ 4 in the study eye
• A total lissamine green conjunctival score of ≥ 2 in the study eye
• Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.

Exclusion Criteria:

• Any clinically significant slit lamp finding
• Any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation
• Any keratorefractive surgery within the last 12 months
• Any intraocular or extraocular surgery within 3 months