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Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Primary Purpose

Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lumega-Z
Dorzolamide Hcl 2% Oph Soln
Placebo
Sponsored by
University of the Incarnate Word
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glaucoma focused on measuring Lumega-Z, Macular Pigment, Macular Pigment Optical Density, Contrast Sensitivity, Humphrey Visual Field 10-2, Dermal Carotenoid, MapcatSF, Veggie Meter, Vector Vision, Pericentral Visual Field

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00)
  • Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months
  • Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF)
  • Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters

Exclusion Criteria:

  • BCVA worse than 20/200
  • Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures
  • Loss of IOP control requires surgical intervention
  • Patient already taking AREDS formula oral supplement
  • Patient taking medication or dietary supplements that may interact with LM ingredients
  • History of photosensitive epilepsy
  • History of penetrating ocular trauma or vitrectomy
  • History of ocular or orbital radiation therapy or is currently receiving chemotherapy
  • Women who are nursing, pregnant, or are planning pregnancy
  • Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid.
  • Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment.
  • Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment
  • Native lens opacity ≥ grade 3 on ARLNS standard photograph
  • Blue light filter intraocular lens

Sites / Locations

  • Ophtalmology Clinic of William E Sponsel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months.

Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months.

Outcomes

Primary Outcome Measures

Pericentral Visual Function
Mean deviation and pattern standard deviation of 10-2 Humphrey visual field

Secondary Outcome Measures

Macular Pigment Optical Density
Macular Pigment Optical Density measured by Mapcat SF
Dermal Carotenoid Levels
Measured by Veggie Meter
Contrast Sensitivity
Measured by Vector Vision CSV-2000

Full Information

First Posted
December 9, 2020
Last Updated
September 30, 2022
Sponsor
University of the Incarnate Word
Collaborators
Guardion Health Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04676126
Brief Title
Augmented Macular Pigment-containing Nutraceutical and Central Visual Function
Official Title
Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
IRB records show administrative closure on 12/16/21. No subjects enrolled.
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Incarnate Word
Collaborators
Guardion Health Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (Lumega-Z), in combination with a topical carbonic anhydrase inhibitor.
Detailed Description
This is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (Lumega-Z). Participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. All packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. Both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
Keywords
Lumega-Z, Macular Pigment, Macular Pigment Optical Density, Contrast Sensitivity, Humphrey Visual Field 10-2, Dermal Carotenoid, MapcatSF, Veggie Meter, Vector Vision, Pericentral Visual Field

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective double-masked, randomized controlled study which compares pre- supplementation macular pigment optical density, contrast sensitivity, dermal carotenoid levels, and visual field status to post-supplement measurements of the same.
Masking
ParticipantCare ProviderInvestigator
Masking Description
A remotely located Guardion Health Sciences designee will utilize a computer-generated random number table to assign patients to placebo or experimental group. Subjects will have the supplement/placebo delivered to their homes in identical (except lot number) packaging.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Subjects in the experimental arm will consume 1.5 Tbsp (22.2 mL) of a commercial macular pigment-containing medical food (liquid) once per day and use a carbonic anhydrase inhibitor topical eye drop (2% dorzolamide ophthalmic solution) three times per day in both eyes for 3 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in the placebo arm will consume 1.5 Tbsp (22.2 mL) of a placebo liquid which resembles the commercial macular pigment-containing medical food (liquid) in taste once per day and use a lubricating eye drop (0.5% sodium + 0.9% glycerin ophthalmic solution) three times per day in both eyes for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lumega-Z
Intervention Description
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
Intervention Type
Drug
Intervention Name(s)
Dorzolamide Hcl 2% Oph Soln
Other Intervention Name(s)
Azopt
Intervention Description
Topical carbonic anhydrase inhibitor
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study
Primary Outcome Measure Information:
Title
Pericentral Visual Function
Description
Mean deviation and pattern standard deviation of 10-2 Humphrey visual field
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Macular Pigment Optical Density
Description
Macular Pigment Optical Density measured by Mapcat SF
Time Frame
Monthly for 3 months
Title
Dermal Carotenoid Levels
Description
Measured by Veggie Meter
Time Frame
Monthly for 3 months
Title
Contrast Sensitivity
Description
Measured by Vector Vision CSV-2000
Time Frame
Monthly for 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Glaucoma diagnosis (H40. *) with abnormal visual field as measured by 30-2 Humphrey Perimetry (mean deviation < -2.00) Adequate IOP control (IOP > 7 mmHg and < 22 mmHg) by medical or surgical means measured by Goldman Applanation Tonometry for at least 3 months Visual field progression - decrease (more negative) in MD by 1.00 dB or more when compared to prior HVF) Refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters Exclusion Criteria: BCVA worse than 20/200 Pt Is unable to tolerate MPOD, CS, dermal carotenoid measurement-taking procedures Loss of IOP control requires surgical intervention Patient already taking AREDS formula oral supplement Patient taking medication or dietary supplements that may interact with LM ingredients History of photosensitive epilepsy History of penetrating ocular trauma or vitrectomy History of ocular or orbital radiation therapy or is currently receiving chemotherapy Women who are nursing, pregnant, or are planning pregnancy Has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: N-acetyl-cysteine, acetyl-L-carnitine, L-taurine, quercetin, Co-enzyme Q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid. Currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment. Is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery < 3 months before enrollment Native lens opacity ≥ grade 3 on ARLNS standard photograph Blue light filter intraocular lens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant T Slagle, DO
Organizational Affiliation
Sponsel Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophtalmology Clinic of William E Sponsel
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD to other researches.
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Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

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