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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03879863
The ClinicalTrials.gov registry entry for NCT03879863 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 422 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 85-participant average among 41 other Dry Eye trials with a reported enrollment target (396% higher). The listed sponsor is Aldeyra Therapeutics, which has 26 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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