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NCT03879863 · ClinicalTrials.gov registry record · Phase 3
The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
A Phase 3 study of Dry Eye, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 422
- Enrollment target
- 1
- Study location
NCT03879863: Completed Phase 3 study of Dry Eye, sponsored by Aldeyra Therapeutics.
NCT03879863 is a Phase 3 study of Dry Eye that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 422 participants, above the 85-participant average among 41 other Dry Eye trials with a reported enrollment target (396% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03879863, a Phase 3 study of Dry Eye, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 422 participants
- Enrollment target
- 1
- Study location
Study Summary
The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution 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.
Conditions Studied
Interventions
- DRUG Reproxalap Ophthalmic Solution (0.25%) QID
- DRUG Vehicle Ophthalmic Solution QID
- DRUG Reproxalap Ophthalmic Solution (0.25%) QID to BID
- DRUG Vehicle Ophthalmic Solution QID to BID
Study Locations (1)
California
- Eye Research Foundation - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 422 participants |
| Start Date | 2019-04-16 |
| Est. Completion | 2019-10-04 |
| Phase | Phase 3 |
What the finished NCT03879863 record still lists
NCT03879863 is an interventional study that assigns participants to a tested intervention. The registered 422 participants enrollment target is mid-sized for trials with a published cap, above the 85-participant average among 41 other Dry Eye trials with a reported enrollment target (396% higher).
The record links to 1 condition, with Dry Eye appearing as the primary indexed condition, and to 4 interventions - of which Reproxalap Ophthalmic Solution (0.25%) QID is the first listed.
NCT03879863 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03879863 about?
NCT03879863 is a clinical study titled "The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease". The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
What is the current status of trial NCT03879863?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 422 participants. The study started on 2019-04-16. Estimated completion is 2019-10-04.
What conditions does trial NCT03879863 study?
This clinical trial studies the following conditions: Dry Eye.
What interventions are being tested in trial NCT03879863?
The interventions under investigation include: Reproxalap Ophthalmic Solution (0.25%) QID (DRUG), Vehicle Ophthalmic Solution QID (DRUG), Reproxalap Ophthalmic Solution (0.25%) QID to BID (DRUG), Vehicle Ophthalmic Solution QID to BID (DRUG).
Who is sponsoring clinical trial NCT03879863?
This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03879863 being conducted?
This trial has 1 study location across California. 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 NCT03879863's enrollment target sits among peer trials
422 2nd of 41 the highest 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.
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