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Completed

NCT Number: NCT06293820

A Study Of TL-925 For The Treatment of AC

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TL-925

Drug

TL-925 is an eye drop.

Placebo

Drug

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

Primary outcomes

  1. Ocular Itching

    Time frame: 3, 5 and 7 minutes after CAC

    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).

  2. Conjunctival Redness

    Time frame: 7, 15 and 20 minutes after CAC

    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).

Sponsors and collaborators

Lead sponsor

Telios Pharma, Inc.

Industry

Registry information

Official study title

A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2b 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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