ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis

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

Intervention / Treatment
-----------------
* Drug: Reproxalap Ophthalmic Solution (0.25%)
* Drug: Reproxalap Ophthalmic Solution (0.5%)
* Drug: Vehicle Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be at least 18 years of age of either gender and any race have a positive history of ocular allergies and a positive skin test reaction to a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months; have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart Exclusion Criteria: have known contraindications or sensitivities to the use of the investigational product or any of its components have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye) have had ocular surgical intervention within three (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after have a known history of retinal detachment, diabetic retinopathy, or active retinal disease have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1

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 |
| --- | --- |
| Experimental: Reproxalap Ophthalmic Solution (0.25%)<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) administered once.<br>|
| Experimental: Reproxalap Ophthalmic Solution (0.5%)<br> | Drug: Reproxalap Ophthalmic Solution (0.5%)<br>* Reproxalap Ophthalmic Solution (0.5%) administered once.<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution administered once.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching evaluated by the Subject. | The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale | Efficacy assessment period (Day -21 through Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival redness | The method of assessment for this outcome is the Ora Calibra(TM) Ocular Hyperemia Scale | Efficacy assessment period (Day -21 through Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reproxalap