Status:
COMPLETED
A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06493604
Start Date
June 24 2024
End Date
February 27 2025
Last Update
December 22 2025
Active Locations (1)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810