NCT06686472 · Telios Pharma, Inc.
Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis
What this study is about
In this forward-looking, Phase 2, randomly assigned, double-masked, vehicle controlled study, approximately 66 eligible subjects will be randomly assigned 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.
View original scientific description
In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 66 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Memphis, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 13, 2024 · Source of record for eligibility and locations