A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
← catalyst calendarSponsored by Aldeyra Therapeutics, Inc. (industry) · ALDX — their whole pipeline →.
Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
116actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-06-24 | actual | When the study began enrolling |
| Primary completion | 2025-02-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-02-27 | actual | The whole study's end, after follow-up |
| First posted | 2024-07-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Dry Eye Disease
Interventions
- Drug: Reproxalap Ophthalmic Solution (0.25%)
- Drug: Vehicle Ophthalmic Solution
Primary outcome
what the primary-completion date above is the date OFOcular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3
measured Day -14 to Day 2
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-04-19 · 4.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-06-20 · 338 KB · SAP_001.pdf
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