TL-925 eye drops for allergic conjunctivitis
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
Run by Telios Pharma, Inc. · NCT07220408 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Telios Pharma, Inc. Industry-sponsored |
| Locations | 1 site (Smyrna, Tennessee) |
| Status | Recruiting |
| Started | October 23, 2025 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT07220408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Advancing Vision Research
Smyrna, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Yulia Khalina
- Email: ykhalina@teliospharma.com
- Phone: 908-656-2799
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.