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NCT04735393 · ClinicalTrials.gov registry record · Phase 3
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
A Phase 3 study, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 757
- Enrollment target
NCT04735393: Completed Phase 3 study, sponsored by Aldeyra Therapeutics.
NCT04735393 is a Phase 3 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 757 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04735393, a Phase 3 study, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 757 participants
- Enrollment target
Study Summary
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease
Primary Outcome
The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.
Interventions
- DRUG Placebo Comparator
- DRUG Reproxalap Ophthalmic Solution (0.25%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 757 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2022-10-11 |
| Phase | Phase 3 |
What the finished NCT04735393 record still lists
NCT04735393 is an interventional study that assigns participants to a tested intervention. The registered 757 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT04735393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04735393 about?
NCT04735393 is a clinical study titled "A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease". A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease
What is the current status of trial NCT04735393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 757 participants. The study started on 2021-01-26. Estimated completion is 2022-10-11.
What interventions are being tested in trial NCT04735393?
The interventions under investigation include: Placebo Comparator (DRUG), Reproxalap Ophthalmic Solution (0.25%) (DRUG).
Who is sponsoring clinical trial NCT04735393?
This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04735393's enrollment target sits among peer trials
757 456th of 2000 higher than 1,544 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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