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A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
Sponsor: Telios Pharma, Inc.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
880
Start Date
2024-02-06
Completion Date
2024-12
Last Updated
2024-07-10
Healthy Volunteers
No
Conditions
Interventions
TL-925
TL-925 is an eye drop.
Placebo
The composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient.
Locations (18)
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