NCT06225973

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Telios Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Dry Eye Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-06
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-01-26
• Last updated: 2024-07-10

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study