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

Phase 1

Completed

Interventions: Drug: Reproxalap Ophthalmic Solution (0.5%)
Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Ophthalmic Solution

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.5%)	Reproxalap Ophthalmic Solution (0.5%)	-
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline Ocular Itching Score on High Pollen Days	Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.	Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.

Secondary Outcome Measures