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

July 8, 2024 updated by: Telios Pharma, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

880

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Cornea and Cataract Consultants of Arizona
    • California
      • Glendale, California, United States, 91204
        • Global Research Management
      • La Mesa, California, United States, 91942
        • Nvision - La Mesa
      • Torrance, California, United States, 90505
        • Nvision - Torrance
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Wyse Eyecare
    • Indiana
      • Columbus, Indiana, United States, 47203
        • Pankratz Eye
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Butchertown Clinical
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Andover Eye Associates - Andover
      • Raynham, Massachusetts, United States, 02767
        • Andover Eye Associates - Raynham
      • Westborough, Massachusetts, United States, 01581
        • NEERA - Westborough
      • Woburn, Massachusetts, United States, 01801
        • NEERA - Woburn
    • North Carolina
      • Garner, North Carolina, United States, 27529
        • Oculus Research
      • Leland, North Carolina, United States, 28451
        • Wilmington Eye
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott and Christie EyeCare Associates
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Advancing Vision Research
      • Memphis, Tennessee, United States, 38119
        • Total Eye Care, PA
      • Smyrna, Tennessee, United States, 37167
        • Advancing Vision Research
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 a highly effective contraception method during the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TL-925 Arm
TL-925 will be administered OU BID
Drug: TL-925
TL-925 is an eye drop.
Placebo Comparator: Vehicle Arm
Vehicle will be administered OU BID
Other: Placebo
The composition of the vehicle is identical to the active formulation except for the exclusion of the active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the efficacy of TL-925 compared to vehicle on tear production
Time Frame: Baseline to Day 29
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score
Baseline to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telios Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL-925-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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