The INVIGORATE 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 Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.

Detailed Description
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The INVIGORATE Trial: A 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 Trial: A 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 of either gender and any race have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement have a positive skin prick test to ragweed pollen within the past year of screening Exclusion Criteria: known contraindication or hypersensitivities to any components of the investigational product medication or components history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis; presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial; diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus woman of childbearing potential who is pregnant or nursing

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 |
| --- | --- |
| Active Comparator: Reproxalap Ophthalmic Solution (0.25%)<br> | Drug: Reproxalap Ophthalmic Solution (0.25%)<br>* Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.<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 sever). | During EEC allergen exposure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproxalap, INVIGORATE, ADX-102