Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TL-925, Placebo.
- Who it may be relevant to
- Registry conditions: Allergic Conjunctivitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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 Seasonal Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
Overview
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.
Interventions
- Drug TL-925
TL-925 is an eye drop. - Drug Placebo
The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.
Primary outcome measures
- Ocular Itching [Time frame: 3, 5 and 7 minutes after CAC]
- Conjunctival Redness [Time frame: 7, 15 and 20 minutes after CAC]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Advancing Vision Research — Smyrna
Identifiers
NCT: NCT07220408 · TL-925-314