Augmented Macular Pigment-containing Nutraceutical and Central Visual Function
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04676126 |
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Recruitment Status :
Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
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Sponsor:
University of the Incarnate Word
Collaborator:
Guardion Health Sciences, Inc.
Information provided by (Responsible Party):
University of the Incarnate Word
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glaucoma Glaucoma Eye Glaucoma, Open-Angle | Dietary Supplement: Lumega-Z Drug: Dorzolamide Hcl 2% Oph Soln Other: Placebo | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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: | Triple (Participant, Care Provider, Investigator) |
| 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. |
| Primary Purpose: | Prevention |
| Official Title: | Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial |
| Estimated Study Start Date : | January 2021 |
| Estimated Primary Completion Date : | July 2021 |
| Estimated Study Completion Date : | January 2022 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Dorzolamide
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental
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.
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Dietary Supplement: Lumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin Drug: Dorzolamide Hcl 2% Oph Soln Topical carbonic anhydrase inhibitor
Other Name: Azopt |
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Placebo Comparator: Placebo
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.
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Other: Placebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study |
Primary Outcome Measures :
- Pericentral Visual Function [ Time Frame: 3 Months ]Mean deviation and pattern standard deviation of 10-2 Humphrey visual field
Secondary Outcome Measures :
- Macular Pigment Optical Density [ Time Frame: Monthly for 3 months ]Macular Pigment Optical Density measured by Mapcat SF
- Dermal Carotenoid Levels [ Time Frame: Monthly for 3 months ]Measured by Veggie Meter
- Contrast Sensitivity [ Time Frame: Monthly for 3 months ]Measured by Vector Vision CSV-2000
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT04676126
Contacts
| Contact: Grant T Slagle, DO | 2102239292 ext 108 | slaglegrant@gmail.com | |
| Contact: William E Sponsel, MD | 2102239292 | sponsel@uiwtx.edu |
Locations
| United States, Texas | |
| Ophtalmology Clinic of William E Sponsel | |
| San Antonio, Texas, United States, 78215 | |
| Contact: Joanne Office Manager, COT 210-223-9292 | |
Sponsors and Collaborators
University of the Incarnate Word
Guardion Health Sciences, Inc.
Investigators
| Principal Investigator: | Grant T Slagle, DO | Sponsel Foundation |
Study Documents (Full-Text)
Documents provided by University of the Incarnate Word:
Documents provided by University of the Incarnate Word:
Informed Consent Form [PDF] December 17, 2020
Study Protocol and Statistical Analysis Plan [PDF] December 17, 2020
Publications:
| Responsible Party: | University of the Incarnate Word |
| ClinicalTrials.gov Identifier: | NCT04676126 |
| Other Study ID Numbers: |
20-11-005 |
| First Posted: | December 19, 2020 Key Record Dates |
| Last Update Posted: | December 19, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | There is no plan to share IPD to other researches. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University of the Incarnate Word:
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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 |
Additional relevant MeSH terms:
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Glaucoma Glaucoma, Open-Angle Ocular Hypertension Eye Diseases Dorzolamide |
Antihypertensive Agents Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |