A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis

Study Overview
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Brief Summary
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A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.

Official Title
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A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Reproxalap Ophthalmic Solution (0.25%)
* Drug: Reproxalap Ophthalmic Solution (0.5%)
* 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 a positive history of ocular allergies and a positive skin test reaction to ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1 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 any of the investigational product medication or 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 months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after; have a known history of retinal detachment, diabetic retinopathy, or active retinal disease have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit; be a female who is currently pregnant, planning a pregnancy, or lactating

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: 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 four times a day and an additional four times a day on an as needed basis.<br>|
| Experimental: Reproxalap Ophthalmic Solution (0.5%)<br> | Drug: Reproxalap Ophthalmic Solution (0.5%)<br>* Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br> | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.<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, safety, and tolerability. | The method of assessment for this outcome is the Ora Calibra(TM) Conjunctival Allergen Challenge Ocular Itching Scale. | Efficacy assessment period (Day 1 through Day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event assessment. | Collection of adverse events. | Safety assessment period (Day 1 through Day 29) |