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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-08

Study Completion Date

2019-11-19

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.

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Reproxalap Ophthalmic Solution (0.25%)

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.25%)

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.

Reproxalap Ophthalmic Solution (0.5%)

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.5%)

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.

Vehicle Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type DRUG

Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

Interventions

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Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.5%)

Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.

Intervention Type DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No