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NCT05062330 · ClinicalTrials.gov registry record · Phase 3
The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
A Phase 3 study of Dry Eye, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 361
- Enrollment target
- 1
- Study location
NCT05062330: Completed Phase 3 study of Dry Eye, sponsored by Aldeyra Therapeutics.
NCT05062330 is a Phase 3 study of Dry Eye that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 361 participants, above the 87-participant average among 41 other Dry Eye trials with a reported enrollment target (315% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05062330, a Phase 3 study of Dry Eye, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 361 participants
- Enrollment target
- 1
- Study location
Study Summary
The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 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 Schirmer test (0 to 35 mm). Higher scores represent greater tear production. The least squares mean (standard error) was derived from a mixed model repeated measures analysis of change from baseline, with baseline as a covariate, and time point and treatment group as factors.
Conditions Studied
Interventions
- DRUG Vehicle Ophthalmic Solution
- DRUG Reproxalap Ophthalmic Solution (0.25%)
Study Locations (1)
Massachusetts
- Andover Eye Associates (Raynham) - Raynham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2021-08-28 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 3 |
What the finished NCT05062330 record still lists
NCT05062330 is an interventional study that assigns participants to a tested intervention. The registered 361 participants enrollment target is mid-sized for trials with a published cap, above the 87-participant average among 41 other Dry Eye trials with a reported enrollment target (315% higher).
The record links to 1 condition, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which Vehicle Ophthalmic Solution is the first listed.
NCT05062330 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05062330 about?
NCT05062330 is a clinical study titled "The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease". The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 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 NCT05062330?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 361 participants. The study started on 2021-08-28. Estimated completion is 2022-03-04.
What conditions does trial NCT05062330 study?
This clinical trial studies the following conditions: Dry Eye.
What interventions are being tested in trial NCT05062330?
The interventions under investigation include: Vehicle Ophthalmic Solution (DRUG), Reproxalap Ophthalmic Solution (0.25%) (DRUG).
Who is sponsoring clinical trial NCT05062330?
This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05062330 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05062330's enrollment target sits among peer trials
361 3rd of 41 higher than 39 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye 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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