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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telios Pharma, Inc.

Criteria

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:

• 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)