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NCT04674358 · ClinicalTrials.gov registry record · Phase 2
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
A Phase 2 study, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 329
- Enrollment target
NCT04674358: Completed Phase 2 study, sponsored by Aldeyra Therapeutics.
NCT04674358 is a Phase 2 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 329 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (147% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04674358, a Phase 2 study, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 329 participants
- Enrollment target
Study Summary
The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.
Primary Outcome
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
Interventions
- DRUG Reproxalap Ophthalmic Solution (0.25%)
- DRUG Vehicle Opthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2020-11-21 |
| Est. Completion | 2021-09-12 |
| Phase | Phase 2 |
What the finished NCT04674358 record still lists
NCT04674358 is an interventional study that assigns participants to a tested intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (147% higher).
The record links to 0 conditions, and to 2 interventions - of which Reproxalap Ophthalmic Solution (0.25%) is the first listed.
NCT04674358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04674358 about?
NCT04674358 is a clinical study titled "The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease". The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.
What is the current status of trial NCT04674358?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 329 participants. The study started on 2020-11-21. Estimated completion is 2021-09-12.
What interventions are being tested in trial NCT04674358?
The interventions under investigation include: Reproxalap Ophthalmic Solution (0.25%) (DRUG), Vehicle Opthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT04674358?
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 NCT04674358's enrollment target sits among peer trials
329 146th of 2000 higher than 1,855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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