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Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD) (AMD)

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ClinicalTrials.gov Identifier: NCT03946085
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Western University of Health Sciences
Eye Clinic of Austin
Information provided by (Responsible Party):
Guardion Health Sciences, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Retinal Drusen Age-related Macular Degeneration Macular Degeneration Dietary Supplement: Lumega-Z Dietary Supplement: AREDS2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel treatment group participants will be randomly assigned either the experimental intervention, Lumega-Z, or the AREDS2 supplement. An observational, control group will be included for further comparison.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of a Micronized, Lipid-based Carotenoid Supplement in Eyes With Retinal Drusen
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : October 23, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lumega-Z group
Participants assigned the study supplement Lumega-Z.
Dietary Supplement: Lumega-Z
A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.
Other Name: LMZ

Active Comparator: AREDS2 group
Participants assigned the AREDS2 supplement
Dietary Supplement: AREDS2
A commercially-available multivitamin soft gel formula.
Other Name: Preservision Age-Related Eye Disease Study 2 (AREDS2)

No Intervention: Control
Participants are determined ocular normal after clinical examination and do not have retinal drusen.



Primary Outcome Measures :
  1. Mean Changes in Visual Acuity (VA) [ Time Frame: Baseline, 3-months, and 6-months ]

    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 of 0.00 - 0.20 are considered "good/normal visual acuity scores"; total range of 0.00 - 1.00. Scores are reported as averaged values, according to each respective group of participants and time-point from which the measurements were collected (i.e. baseline, 3-months, etc...).

    Exclusion criteria included LogMAR scores greater than, or equal to, 0.30 (equivalent to visual acuity of 20/40 or worse).


  2. Mean Changes in Contrast Sensitivity (CS) [ Time Frame: Baseline, 3-months, and 6-months ]

    Contrast Sensitivity Function (CSF) was measured using the CSV-1000E device and measurements were analyzed as logCS units (logarithm of Contrast Sensitivity). The device measures both high- and low-contrast sensitivity (participant's ability to discern size and contrast) within a detection task, and reported as a response-curve. The curve compares the lowest contrast-level for a specific-sized target (across four spatial frequencies; per the manufacturer). Thus, the logCS unit of Contrast Sensitivity, is inversely related to the target's contrast level (displayed by the device). All measurements are reported as averaged values within each group, according to their respective time-frame within the study.

    Normal LogCS scores for adults aged 50-75 years old, in ascending order of spatial frequency (3, 6, 12, and 18), are (1.56 +/- 0.15), (1.80 +/- 0.165), (1.50 +/- 0.15), and (0.93 +/- 0.25). Values were utilized for scale, as recommended by the manufacturer/protocol.


  3. Mean Changes in Dark Adaptation Recovery (DAR) [ Time Frame: Baseline, 3-months, and 6-months ]

    DAR measurements were collected using the AdaptDx adaptometer, to identify the participant's impaired dark adaptation threshold value (in response to low-light condition sensitivity). The device's software reported each patient's sensitivity-value over units of time (minutes), and were recorded as units of Rod Intercept Time. Similarly, measurements reported from each group were an averaged value amongst participant groups at each time-point of collection.

    According to the manufacturing protocol, a Rod Intercept Time of 6.5 minutes was determined to be the cut-off value for part of the inclusion criteria into treatment groups. Previous studies have demonstrated that scores equal to, or greater than, 6.5 minutes are indicative of early-AMD, and those less than 6.5 minutes are considered normal Rod Intercept values.


  4. Mean Changes in Macular Pigment Optical Density (MPOD) [ Time Frame: Baseline, 3-months, and 6-months ]

    MPOD levels were measured by heterochromatic flicker photometry, using the MapCatSF device. MPOD (Macular Pigment Optical Density) measurements represent the level of light absorption by the macular pigment within the central retina, and provide measurements related to macular carotenoid densities. Measurements were reported as LogMAR units (total range of 0.00 to 1.00), as determined by the manufacture software program. Averaged values were reported within each group, at each time-point of collection.

    MPOD values between 0.22 - 0.44 logMAR units have been determined to be middle-range MPOD levels; average value in the USA approximately 0.35. Measurements between (0.0 - 0.21) were considered low-MPOD levels, and those between (0.45 - 1.0) were considered high-MPOD levels. All ranged-scores were obtained by recommendation from the manufacturer.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- patients with retinal drusen (as determined by clinical fundus photography examination) and dark adaptation recovery time of 6 to 10 minutes.

Exclusion Criteria:

  • presence of congenital retinal pathologies that may impact data collection
  • prior history of retinal-detachment or vitreo-retinal surgeries with any complications
  • best-corrected visual acuity of 20/40 or worse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946085


Locations
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United States, Texas
Eye Clinic of Austin
Austin, Texas, United States, 78731
Sponsors and Collaborators
Guardion Health Sciences, Inc.
Western University of Health Sciences
Eye Clinic of Austin
Investigators
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Principal Investigator: T Henderson Eye Clinic of Austin
  Study Documents (Full-Text)

Documents provided by Guardion Health Sciences, Inc.:

Additional Information:
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Responsible Party: Guardion Health Sciences, Inc.
ClinicalTrials.gov Identifier: NCT03946085     History of Changes
Other Study ID Numbers: Protocol Number 2
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD underlying the results in a publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guardion Health Sciences, Inc.:
Lumega-Z
Carotenoid supplement
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Drusen
Retinal Degeneration
Retinal Diseases
Eye Diseases
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs