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

Phase 2Active Not RecruitingNCT06225973

Telios Pharma, Inc.880 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

880

Conditions

Dry Eye Disease

Interventions

TL-925DRUG

TL-925 is an eye drop.

PlaceboOTHER

The composition of the vehicle 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: * 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

Locations (18)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States

Global Research Management

Glendale, California, United States

Outcomes

Primary Outcomes

To evaluate the efficacy of TL-925 compared to vehicle on tear production

Percentage of subjects who achieve ≥10 mm improvement in Schirmer's test score

Time frame: Baseline to Day 29

Data from ClinicalTrials.gov

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