RecruitingPhase 2NCT06686472

Evaluation 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

Sponsor

Telios Pharma, Inc.

Enrollment

66 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

allergic conjunctivitis

Summary

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 66 eligible subjects 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Individuals aged 18 years or older
Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
Calculated best-corrected visual activity of 0.7 LogMAR or better
Positive bilateral CAC reaction

Exclusion Criteria3

Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
Any ongoing ocular infection (bacterial, viral or fungal)

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