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NCT04163328 · ClinicalTrials.gov registry record · Phase 4
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT04163328: Clinical Trial Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT04163328 is a Phase 4 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04163328, a Phase 4 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry eye patients who were not contact lens wearers and found that symptoms and corneal smoothness improved in response to HydroEye® supplementation. To date, HydroEye® has not been assessed in patients with contact lens discomfort; therefore, the purpose of this clinical trial is to determine the efficacy of HydroEye® as a treatment for contact lens discomfort.
Primary Outcome
The CLDEQ-8 is a contact lens specific symptoms survey, range = 0-37 with 37 being most symptomatic.
Interventions
- DRUG HydroEye®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-09-16 |
| Est. Completion | 2024-08-21 |
| Phase | Phase 4 |
Why NCT04163328 stopped before completion
NCT04163328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which HydroEye® is the first listed.
NCT04163328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04163328 about?
NCT04163328 is a clinical study titled "Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort". HydroEye® is a dietary omega 3 fatty acid supplement that contains both EPA and DHA, as well as GLA and ALA in the form of black currant seed oil. It also has vitamins A, E, C, B6, and magnesium, many of which are involved in fatty acid metabolism. In 2013, Sheppard et al. tested HydroEye® in dry ey...
What is the current status of trial NCT04163328?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2022-09-16. Estimated completion is 2024-08-21.
What interventions are being tested in trial NCT04163328?
The interventions under investigation include: HydroEye® (DRUG).
Who is sponsoring clinical trial NCT04163328?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04163328's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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