Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis
ConditionAllergic Conjunctivitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelios Pharma, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- TL-925
- Placebo
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov