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

TL-925-303

In this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 670 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.

2024-02-06

2024-12-01

2024-12-01

Recruiting

Early phase I

670

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The Sponsor, Investigators and study staff will be masked during the randomization process and throughout the study. The study site will have the capacity to unmask participants in an emergency.\n\nFollowing completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject and the database has been locked.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 670, 'type': 'ESTIMATED'}}

2024-03-15