Treatment of allergic conjunctivitis with TL-925 eye drops
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 Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
This study is testing if TL-925 eye drops can help people with allergic conjunctivitis feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Telios Pharma, Inc. Industry-sponsored |
| Locations | 1 site (Andover, Massachusetts) |
| Trial ID | NCT06153342 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates the efficacy of TL-925, a topical ophthalmic eye drop, in treating allergic conjunctivitis. Approximately 70 participants will be randomly assigned to receive either TL-925 or a placebo in a double-masked manner. The study utilizes a conjunctival allergen challenge model to assess the treatment's effectiveness over a defined screening and treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a documented history of ocular allergies and a positive reaction to specific allergens.
Not a fit: Patients with ongoing ocular infections or recent ocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms for patients suffering from allergic conjunctivitis.
How similar studies have performed: Other studies have shown promise in treating allergic conjunctivitis with similar approaches, but the specific efficacy of TL-925 is yet to be established.
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 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)
Where this trial is running
Andover, Massachusetts
- Andover Eye Associates — Andover, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: John Mei
- Email: jmei@teliospharma.com
- Phone: (650) 542-0136
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.