The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis

Study Overview
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Brief Summary
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The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).

Official Title
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The INVIGORATE 2 Trial: A Single-center, Randomized, Double-masked, Crossover Design, Vehicle-controlled, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)

Conditions
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Allergic Conjunctivitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age at the time of screening of either sex or any race; Provide written informed consent; Be willing and able to follow instructions, and can attend all required clinical trial visits. Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement; Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1). Exclusion Criteria: Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis; Have systemic signs of infection (e.g., fever, current treatment with antibiotics). Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease; Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception; Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover 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%) dosed twice.<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution dosed twice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching evaluated by the Subject. | The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe). | During EEC allergen exposure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival redness evaluated by the Subject. | The method of assessment for the key secondary outcome is a 9-point ocular redness scale (0 none - 4 extremely severe). | During EEC allergen exposure. |