A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

Aldeyra Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Dry Eye Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06493604

ADX-102-DED-032

Details and patient eligibility

About

A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Full description

Dry eye chamber challenge trial

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age (either gender and any race)
• Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form
• Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
• Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion criteria

• Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
• Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
• Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
• Previous laser-assisted in situ keratomileusis surgery within the last 12 months
• Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial
• Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution administered six times over two consecutive days

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution