A Study Of TL-925 For The Treatment of AC

Telios Pharma

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Placebo; Drug: TL-925

Study type: Interventional

Funder types: Industry

Identifiers

NCT06293820

TL-925-304

Details and patient eligibility

About

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

TL-925 Arm

Active Comparator group

Description:

Subjects will be dosed in clinic and at home.

Treatment:

Drug: TL-925

Placebo Arm

Placebo Comparator group

Description:

Subjects will be dosed in clinic and at home.

Treatment:

Drug: Placebo