A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Dry Eye Disease
In brief
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.
Key facts
- Study ID
- NCT06225973
- Run by
- Telios Pharma, Inc.
- People needed
- 880
- Starts
- 2024-02-06
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
- Global Research Management — Glendale, California, United States
- Nvision - La Mesa — La Mesa, California, United States
- Nvision - Torrance — Torrance, California, United States
- Wyse Eyecare — Northbrook, Illinois, United States
- Pankratz Eye — Columbus, Indiana, United States
- Butchertown Clinical — Louisville, Kentucky, United States
- Andover Eye Associates - Andover — Andover, Massachusetts, United States
- Andover Eye Associates - Raynham — Raynham, Massachusetts, United States
- NEERA - Westborough — Westborough, Massachusetts, United States
- NEERA - Woburn — Woburn, Massachusetts, United States
- Oculus Research — Garner, North Carolina, United States
- Wilmington Eye — Leland, North Carolina, United States
- Scott and Christie EyeCare Associates — Cranberry Township, Pennsylvania, United States
- Advancing Vision Research — Goodlettsville, Tennessee, United States
- Total Eye Care, PA — Memphis, Tennessee, United States
- Advancing Vision Research — Smyrna, Tennessee, United States
- Piedmont Eye Center — Lynchburg, Virginia, United States
Full record on ClinicalTrials.gov
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