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

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

In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or vehicle as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.

Inclusion Criteria:

• 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
• 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
• Best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution
• Any keratorefractive surgery within the last 12 months
• Any intraocular or extraocular surgery within 3 months
• Any blepharoplasty or corneal transplant in either eye
• Any form of punctual, or intracanalicular occlusion in either eye
• History or presence of any ocular disorder that may interfere with study results