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

Telios Pharma, Inc.107 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

107

Conditions

Dry Eye Disease

Interventions

TL-925DRUG

TL-925 is an eye drop.

PlaceboDRUG

The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Aesthetic Eye Care

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Michael Washburn Center for Ophthalmic Research, LLC.

Indianapolis, Indiana, United States

Andover Eye Associates

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Adverse events during screening & treatment period

Time frame: Baseline to the end of day 29 (±2 days)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to the end of day 29 (±2 days)

Data from ClinicalTrials.gov

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