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
Telios Pharma, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria:…
Interventions
- DrugTL-925
TL-925 is an eye drop.
- DrugPlacebo
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
Location
- Telios Investigative SiteMemphis, Tennessee