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

Completed · Phase 3

Conditions studied: Allergic Conjunctivitis

In brief

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

Key facts

Study ID

NCT03494504

Run by

Aldeyra Therapeutics, Inc.

People needed

318

Starts

2018-03-30

Expected to finish

2018-11-05

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornea Consultants of Arizon — Phoenix, Arizona, United States
• Eye Site Sacramento — Sacramento, California, United States
• East West Eye Institute — Torrance, California, United States
• Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Eye Clinics of South Texas — San Antonio, Texas, United States
• R & R Research, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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