Overview
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.
Eligibility
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