Dry Eye Disease
Conditions
Keywords
reproxalap
Brief summary
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
Detailed description
Dry eye chamber challenge trial
Interventions
Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days
DRUGVehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered six times over two consecutive days
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3 | Day -14 to Day 2 | Measured using a 0 - 100 visual analog scale (VAS) where 0 is no discomfort and 100 is maximal discomfort |
Countries
United States
Outcome results
None listed