A Study of TL-925 Ophthalmic Emulsion as a Treatment for Dry Eye Disease
NCT ID: NCT06225973
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
880 participants
INTERVENTIONAL
2024-02-06
2024-12-31
Brief Summary
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The study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Following 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.
Study Groups
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TL-925 Arm
TL-925 will be administered OU BID
TL-925
TL-925 is an eye drop.
Vehicle Arm
Vehicle will be administered OU BID
Placebo
The composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Telios Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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TL-925-303
Identifier Type: -
Identifier Source: org_study_id
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