A Study of TL-925 as a Treatment for Dry Eye Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Dry Eye Disease
In brief
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.
Key facts
- Study ID
- NCT05745064
- Run by
- Telios Pharma, Inc.
- People needed
- 107
- Starts
- 2023-02-27
- Expected to finish
- 2023-07-11
- Last updated by the study team
- 2023-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Aesthetic Eye Care — Newport Beach, California, United States
- Vision Institute — Colorado Springs, Colorado, United States
- Michael Washburn Center for Ophthalmic Research, LLC. — Indianapolis, Indiana, United States
- Andover Eye Associates — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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