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

• Status: Not yet recruiting
• Trial end date: 2023-07-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telios Pharma, Inc.

Criteria

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