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NCT03494504 · ClinicalTrials.gov registry record · Phase 3
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
A Phase 3 study of Allergic Conjunctivitis, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
- 7
- Study locations
NCT03494504: Completed Phase 3 study of Allergic Conjunctivitis, sponsored by Aldeyra Therapeutics.
NCT03494504 is a Phase 3 study of Allergic Conjunctivitis that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 318 participants, above the 119-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (167% higher). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03494504, a Phase 3 study of Allergic Conjunctivitis, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
- 7
- Study locations
Study Summary
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
Primary Outcome
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Conditions Studied
Interventions
- DRUG Vehicle Ophthalmic Solution
- DRUG Reproxalap Ophthalmic Solution (0.25%)
- DRUG Reproxalap Ophthalmic Solution (0.5%)
Study Locations (7)
California
- Eye Site Sacramento - Sacramento
- East West Eye Institute - Torrance
Texas
- Eye Clinics of South Texas - San Antonio
- R & R Research, LLC - San Antonio
Arizona
- Cornea Consultants of Arizon - Phoenix
Maryland
- Seidenberg Protzko Eye Associates - Havre de Grace
Massachusetts
- Andover Eye Associates - Andover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2018-11-05 |
| Phase | Phase 3 |
What the finished NCT03494504 record still lists
NCT03494504 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 119-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (167% higher).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle Ophthalmic Solution is the first listed.
NCT03494504 lists 7 locations in 5 states (California, Texas, Arizona).
Frequently Asked Questions
What is clinical trial NCT03494504 about?
NCT03494504 is a clinical study titled "ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis". A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solutions in Subjects with Acute Allergic Conjunctivitis
What is the current status of trial NCT03494504?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2018-03-30. Estimated completion is 2018-11-05.
What conditions does trial NCT03494504 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT03494504?
The interventions under investigation include: Vehicle Ophthalmic Solution (DRUG), Reproxalap Ophthalmic Solution (0.25%) (DRUG), Reproxalap Ophthalmic Solution (0.5%) (DRUG).
Who is sponsoring clinical trial NCT03494504?
This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03494504 being conducted?
This trial has 7 study locations across Arizona, California, Maryland, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03494504's enrollment target sits among peer trials
318 3rd of 20 higher than 18 of 20 other Allergic Conjunctivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Conjunctivitis 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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