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

Aldeyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Reproxalap Ophthalmic Solution (0.5%); Drug: Vehicle Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03494504

ADX-102-AC-008

Details and patient eligibility

About

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

Enrollment: 318 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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318 participants in 3 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%)

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Reproxalap Ophthalmic Solution (0.5%)

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.5%)

Vehicle Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution