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出境医 / 临床实验 / Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD) (AMD)

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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.



Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: T Henderson Eye Clinic of Austin
Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE January 19, 2018
Actual Primary Completion Date October 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD)
Official Title  ICMJE Clinical Evaluation of a Micronized, Lipid-based Carotenoid Supplement in Eyes With Retinal Drusen
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Retinal Drusen
  • Age-related Macular Degeneration
  • Macular Degeneration
Intervention  ICMJE
  • Dietary Supplement: Lumega-Z
    A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.
    Other Name: LMZ
  • Dietary Supplement: AREDS2
    A commercially-available multivitamin soft gel formula.
    Other Name: Preservision Age-Related Eye Disease Study 2 (AREDS2)
Study Arms  ICMJE
  • Experimental: Lumega-Z group
    Participants assigned the study supplement Lumega-Z.
    Intervention: Dietary Supplement: Lumega-Z
  • Active Comparator: AREDS2 group
    Participants assigned the AREDS2 supplement
    Intervention: Dietary Supplement: AREDS2
  • No Intervention: Control
    Participants are determined ocular normal after clinical examination and do not have retinal drusen.
Publications * Davey PG, Henderson T, Lem DW, Weis R, Amonoo-Monney S, Evans DW. Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula. Nutrients. 2020 Oct 26;12(11). pii: E3271. doi: 10.3390/nu12113271.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date October 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946085
Other Study ID Numbers  ICMJE Protocol Number 2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All IPD underlying the results in a publication
Responsible Party Guardion Health Sciences, Inc.
Study Sponsor  ICMJE Guardion Health Sciences, Inc.
Collaborators  ICMJE
  • Western University of Health Sciences
  • Eye Clinic of Austin
Investigators  ICMJE
Principal Investigator: T Henderson Eye Clinic of Austin
PRS Account Guardion Health Sciences, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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