ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2018-11-05

Brief Summary

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A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute 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 once.

Reproxalap Ophthalmic Solution (0.5%)

Group Type EXPERIMENTAL

Reproxalap Ophthalmic Solution (0.5%)

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.5%) administered once.

Vehicle Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle Ophthalmic Solution

Intervention Type DRUG

Vehicle Ophthalmic Solution administered once.

Interventions

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Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.25%) administered once.

Intervention Type DRUG

Reproxalap Ophthalmic Solution (0.5%)

Reproxalap Ophthalmic Solution (0.5%) administered once.

Intervention Type DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution administered once.

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 a seasonal allergen (grasses, ragweed, and/or trees) as confirmed by an allergic skin test at the Screening Visit or within the past 24 months;
* 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 the investigational product or any of its 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 (3) months prior to Visit 1 or during the trial and/or a history of refractive surgery six (6) months prior to Visit 1 or have ocular or systemic surgery planned during the study or within 30 days after
* have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
* have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit
* be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the trial duration, or has a positive urine pregnancy test at Visit 1

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No