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Recruiting Phase 2

Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis

NCT07220408 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2025-10-23
Last updated
2025-11-25

Condition(s) studied

Allergic Conjunctivitis

Investigational drug(s) / intervention(s)

TL-925 →Placebo

TL-925: TL-925 is an eye drop.

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

Study summary

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 60 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * 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)

Primary outcome measure(s)

  • Ocular Itching — 3, 5 and 7 minutes after CAC
    Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4d , 5d, and 6c.
  • Conjunctival Redness — 7, 15 and 20 minutes after CAC
    Conjunctival redness score will be evaluated by the investigator at 3 timepoints after CAC at Visits 4d, 5d, and 6c.

Trial sites (1)

FacilityCityRegionStatus
Advancing Vision Research Smyrna Tennessee Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220408 on ClinicalTrials.gov ↗ ← All trials in the USA