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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06225973

Enrollment

880

Registered

2024-01-26

Start date

2024-02-06

Completion date

2024-12-31

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease

Brief summary

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.

Interventions

DRUGTL-925

TL-925 is an eye drop.

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

The Sponsor, Investigators and study staff will be masked during the randomization process and throughout the study. The study site will have the capacity to unmask participants in an emergency. Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject and the database has been locked.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026