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



Status:Completed
Conditions:Allergy, Ocular
Therapuetic Areas:Ophthalmology, Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 30, 2018
End Date:November 5, 2018

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A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions (0.25% and 0.5%) Compared to Vehicle in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis

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


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
We found this trial at
7
sites
Sacramento, California 95819
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Andover, Massachusetts 01810
Phone: 617-248-3875
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Andover, MA
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Havre de Grace, Maryland 21078
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Phoenix, Arizona 85032
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San Antonio, Texas 78209
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San Antonio, TX
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7979 Wurzbach Road
San Antonio, Texas 78229
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San Antonio, TX
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23441 Madison Street
Torrance, California 90505
Phone: 310-780-6991
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Torrance, CA
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