Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis
Purpose
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.
Condition
- Allergic Conjunctivitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- The sponsor, investigators, and study staff will be masked throughout the study. The study site will have the capacity to unmask in case of emergency. Following completion of the study, the randomization code will be unmasked once all data has been entered into the study database for every subject, and the database has been locked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator TL-925 Arm |
Subjects will be dosed in clinic. |
|
|
Placebo Comparator Placebo Arm |
Subjects will be dosed in clinic. |
|
Recruiting Locations
Telios Investigative Site
Memphis, Tennessee 38119
Memphis, Tennessee 38119
More Details
- NCT ID
- NCT06686472
- Status
- Recruiting
- Sponsor
- Telios Pharma, Inc.