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NCT03946085 · ClinicalTrials.gov registry record · NA
Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)
A NA study of Age-related Macular Degeneration and Macular Degeneration, sponsored by Guardion Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 79
- Enrollment target
- 1
- Study location
NCT03946085: Completed NA study of Age-related Macular Degeneration and Macular Degeneration, sponsored by Guardion Health Sciences.
NCT03946085 is a NA study of Age-related Macular Degeneration and Macular Degeneration that has completed, run by Guardion Health Sciences. The registered enrollment target is 79 participants, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03946085, a NA study of Age-related Macular Degeneration and Macular Degeneration, has completed, sponsored by Guardion Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the Lumega-Z carotenoid liquid-supplement in participants with drusen and at risk of AMD. The effects of Lumega-Z supplementation will be compared to an active comparator, the AREDS2 multivitamin.
Primary Outcome
Repeated measures were obtained using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart-based acuity exam. The ETDRS chart allows a geometric quantification the participant's visual acuity threshold for images under daylight-conditions of black \& white contrast. Participant scores were reported as Logarithm of the Minimum Angle of Resolution (LogMAR) units; a more accurate, standardized value equated from the similar acuity charts. Per the clinical evaluation protocol, LogMAR scores
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Lumega-Z
- DIETARY_SUPPLEMENT AREDS2
Study Locations (1)
Texas
- Eye Clinic of Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2018-01-19 |
| Est. Completion | 2018-11-01 |
| Phase | NA |
What the finished NCT03946085 record still lists
NCT03946085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,507-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Lumega-Z is the first listed.
NCT03946085 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03946085 about?
NCT03946085 is a clinical study titled "Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)". The aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the Lumega-Z carotenoid liquid-supplement in participants with drusen and at risk of AMD. The effects of Lumega-Z supplementation will be compared to an active comparator, the AREDS2 multivi...
What is the current status of trial NCT03946085?
This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2018-01-19. Estimated completion is 2018-11-01.
What conditions does trial NCT03946085 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration, Macular Degeneration, Retinal Drusen.
What interventions are being tested in trial NCT03946085?
The interventions under investigation include: Lumega-Z (DIETARY_SUPPLEMENT), AREDS2 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03946085?
This trial is sponsored by Guardion Health Sciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03946085 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03946085's enrollment target sits among peer trials
79 38th of 74 higher than 37 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration 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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