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

Last updated: July 8, 2024
Sponsor: Telios Pharma, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Sjogren's Syndrome

Dry Eye Disease

Dry Eyes

Treatment

Placebo

TL-925

Clinical Study ID

NCT06225973
TL-925-303
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 ahighly effective contraception method during the study

Exclusion

Exclusion Criteria:

  • Any clinically significant slit lamp finding

  • Any ongoing ocular infection (bacterial, viral or fungal) or active ocularinflammation

  • 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

Study Design

Total Participants: 880
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 06, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Cornea and Cataract Consultants of Arizona

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Nvision - La Mesa

    La Mesa, California 91942
    United States

    Site Not Available

  • Nvision

    Torrance, California 90505
    United States

    Active - Recruiting

  • Nvision - Torrance

    Torrance, California 90505
    United States

    Site Not Available

  • Wyse Eyecare

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Pankratz Eye

    Columbus, Indiana 47203
    United States

    Site Not Available

  • Butchertown Clinical

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Andover Eye Associates - Andover

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Andover Eye Associates - Raynham

    Raynham, Massachusetts 02767
    United States

    Site Not Available

  • NEERA - Westborough

    Westborough, Massachusetts 01581
    United States

    Site Not Available

  • NEERA - Woburn

    Woburn, Massachusetts 01801
    United States

    Site Not Available

  • Oculus Research

    Garner, North Carolina 27529
    United States

    Site Not Available

  • Wilmington Eye

    Leland, North Carolina 28451
    United States

    Site Not Available

  • Scott and Christie EyeCare Associates

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Advancing Vision Research

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Advancing Vision Research

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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