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

NCT06225973 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2024-07-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TL-925

TL-925 is an eye drop.

OTHER

Placebo

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

Sponsors & Collaborators

  • Telios Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225973 on ClinicalTrials.gov