NCT05745064

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

A Phase 2, Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety and Tolerability of TL-925 Ophthalmic Emulsion 0.1% in Subjects With Moderate to Severe Dry Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Telios Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this prospective, Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, approximately 100 subjects with moderate to severe dry eye disease (DED) will be randomly assigned (1:1) to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally BID. The study will comprise two phases: 2-weeks screening/run-in and 4-weeks double-masked treatment.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	TL-925	TL-925 is an eye drop.
DRUG	Placebo	The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

Timeline

• Start date: 2023-02-27
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2023-02-27
• Last updated: 2023-11-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study