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

A Phase 2, Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety and Tolerability of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease

In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID.

The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: TL-925; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Aesthetic Eye Care
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Michael Washburn Center for Ophthalmic Research, LLC.
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals aged 18 years or older
• 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
• A tear film break-up time (TFBUT) of ≤ 5 seconds in the study eye
• A corneal fluorescein staining score of ≥ 2 in at least one region of the cornea
• A sum corneal fluorescein staining score of ≥ 4 in the study eye
• A total lissamine green conjunctival score of ≥ 2 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
• Any keratorefractive surgery within the last 12 months
• Any intraocular or extraocular surgery within 3 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events during screening & treatment period	Baseline to the end of day 29 (±2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in corneal and conjunctival staining	Fluorescein staining by region in designated study eye will be used. Results will be assessed using a 5-point Corneal and Conjunctival Staining Scale.	Baseline to the end of day 29 (±2 days)
Change from baseline in ocular discomfort	Visual analog scale (VAS) will be used. This will assess patients on a a 7-item 100-point scale based on ocular discomfort.	Baseline to the end of day 29 (±2 days)
Change from baseline visual acuity	Best corrected visual acuity (BCVA) will be used to determine change in visual acuity from baseline.	Baseline to the end of day 29 (±2 days)

Collaborators and Investigators

• Sponsor: Telios Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Phase II; TL-925
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: TL-925-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No