NCT06153342

A Study of TL-925 for the Treatment of Allergic Conjunctivitis

A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2 Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Telios Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally. The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.

Conditions

• Allergic Conjunctivitis

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: 2023-11-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study