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NCT03916042 · ClinicalTrials.gov registry record · Phase 2
A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease
A Phase 2 study, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
NCT03916042: Completed Phase 2 study, sponsored by Aldeyra Therapeutics.
NCT03916042 is a Phase 2 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 206 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916042, a Phase 2 study, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
Study Summary
A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease
Primary Outcome
Change from baseline comparison of reproxalap to vehicle for subject-reported Ocular Dryness Score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher 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 calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Interventions
- DRUG Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
- DRUG Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2019-04-23 |
| Est. Completion | 2019-11-22 |
| Phase | Phase 2 |
What the finished NCT03916042 record still lists
NCT03916042 is an interventional study that assigns participants to a tested intervention. The registered 206 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 (55% higher).
The record links to 0 conditions, and to 2 interventions - of which Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID is the first listed.
NCT03916042 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03916042 about?
NCT03916042 is a clinical study titled "A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease". A Multi-Center, Phase 2, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% Novel Formulation) Compared to Vehicle in Subjects with Dry Eye Disease
What is the current status of trial NCT03916042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2019-04-23. Estimated completion is 2019-11-22.
What interventions are being tested in trial NCT03916042?
The interventions under investigation include: Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID (DRUG), Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID (DRUG).
Who is sponsoring clinical trial NCT03916042?
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 NCT03916042's enrollment target sits among peer trials
206 298th of 2000 higher than 1,703 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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