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

Aldeyra Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Allergic Conjunctivitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03660878

ADX-102-AC-010

Details and patient eligibility

About

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.

Enrollment: 52 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 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