A Study of TL-925 as a Treatment for 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 olderA diagnosis of dry eye disease for at least 6 monthsAn unanesthetized Schirmer's test score (STS) of ≤ 10mm and ≥ 1mm in the study eyeA tear film break-up time (TFBUT) of ≤ 5 seconds in the study eyeA corneal fluorescein staining score of ≥ 2 in at least one region of the corneaA sum corneal fluorescein staining score of ≥ 4 in the study eyeA total lissamine green conjunctival score of ≥ 2 in the study eyeFemale 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 findingAny ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammationAny keratorefractive surgery within the last 12 monthsAny intraocular or extraocular surgery within 3 months