A Study of TL-925 Ophthalmic Emulsion as a Treatment for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cornea and Cataract Consultants of Arizona, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TL-925

Drug

TL-925 is an eye drop.

Placebo

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Telios Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 26, 2024
Registry last updated: Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting