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

Description

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.

Conditions

Allergic Conjunctivitis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Allergic Conjunctivitis
Intervention / Treatment

-

Contacts and Locations

Andover

Andover Eye Associates, Andover, Massachusetts, United States, 01810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Telios Pharma, Inc.,

Study Record Dates

2024-01