A Study of TL-925 for the Treatment of Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis 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.

Official Title
-----------------
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

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: TL-925
* Drug: Placebo


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TL-925 Arm<br>Subjects will be dosed in clinic on days of dosing. | Drug: TL-925<br>* TL-925 is an eye drop.<br>|
| Placebo Comparator: Placebo Arm<br>Subjects will be dosed in clinic on days of dosing. | Drug: Placebo<br>* The composition of the placebo is identical to the active formulation except for the exclusion of the active ingredient.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching | 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). | 3, 5 and 7 minutes after CAC | 
| Conjunctival redness | Conjunctival redness will be assessed 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). | 7, 15 and 20 minutes after CAC | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TL-925, Phase II