A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Completed · Phase 3
Conditions studied: Dry Eye Disease
In brief
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
Key facts
- Study ID
- NCT06493604
- Run by
- Aldeyra Therapeutics, Inc.
- People needed
- 116
- Starts
- 2024-06-24
- Expected to finish
- 2025-02-27
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Andover Eye Associates — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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