A Study Of TL-925 For The Treatment of AC

Telios Pharma, Inc.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

TL-925DRUG

TL-925 is an eye drop.

PlaceboDRUG

The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Ocular Itching

Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).

Time frame: 3, 5 and 7 minutes after CAC

Conjunctival Redness

Conjunctival redness score evaluated by the investigator at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).

Time frame: 7, 15 and 20 minutes after CAC

Data from ClinicalTrials.gov

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