TL-925 eye drops for 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 Seasonal Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
This trial will test whether TL-925 eye drops relieve allergy-related eye redness and itching in adults with seasonal or perennial allergic conjunctivitis using a controlled allergen challenge.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Telios Pharma, Inc. Industry-sponsored |
| Locations | 1 site (Smyrna, Tennessee) |
| Trial ID | NCT07220408 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-masked, vehicle-controlled Phase 2 trial that will enroll about 60 adult participants and randomize them 1:1 to receive TL-925 or placebo eye drops administered to both eyes. The study uses the conjunctival allergen challenge (CAC) model, with screening to confirm allergic sensitization by skin test and a positive bilateral CAC reaction before treatment. Participants and investigators are masked to assignment and outcomes are compared between the TL-925 and vehicle groups during the treatment period. The protocol excludes people with active ocular infection, recent ocular surgery, or other ocular conditions that could confound results.
Who should consider this trial
Good fit: Adults 18 or older with a documented history of ocular allergy, a positive skin allergy test to relevant allergens, and a positive bilateral conjunctival allergen challenge are the intended participants.
Not a fit: People with active ocular infections, recent ocular or refractive surgery, other ocular diseases causing redness or discomfort, or those who do not show a positive allergen challenge are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, TL-925 could offer a topical option that reduces itching, redness, and discomfort from allergic conjunctivitis.
How similar studies have performed: The CAC model is well-established and topical antihistamines/mast-cell stabilizers have shown benefit for allergic conjunctivitis, but TL-925 itself is a novel investigational agent being tested in this setting.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Smyrna, Tennessee
- Advancing Vision Research — Smyrna, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Yulia Khalina
- Email: ykhalina@teliospharma.com
- Phone: 908-656-2799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.