A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2b 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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Telios Pharma, Inc.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Conjunctival Redness
Study Overview
Brief Summary
In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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)
Arms & Interventions
TL-925 Arm
Subjects will be dosed in clinic and at home.
Intervention: TL-925 (Drug)
Placebo Arm
Subjects will be dosed in clinic and at home.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Conjunctival Redness
Time Frame: 7, 15 and 20 minutes after CAC
Conjunctival redness score evaluated by the investigator at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were completed using a 0-4 numerical scale (0 = none and 4 = extremely severe).
Ocular Itching
Time Frame: 3, 5 and 7 minutes after CAC
Ocular itching score will be reported by the subject at 3 timepoints after CAC at Visits 4, 5 and 6. Assessments were reported using a 0-4 numerical scale (0 = none and 4 = incapacitating itch with an irresistible urge to rub).
Secondary Outcomes
No secondary outcomes reported