Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Glaucoma Clinical Trial

Official title:

Augmented Macular Pigment Supplement and Pericentral Visual Function: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04676126
• Other study ID #: 20-11-005
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 2021
• Est. completion date: May 2022

Study information

• Verified date: September 2022
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye
• Glaucoma, Open-Angle

Intervention

Dietary Supplement:
• Lumega-Z
Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin

Drug:
• Dorzolamide Hcl 2% Oph Soln
Topical carbonic anhydrase inhibitor

Other:
• Placebo
Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study

Locations

Country	Name	City	State
United States	Ophtalmology Clinic of William E Sponsel	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of the Incarnate Word	Guardion Health Sciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pericentral Visual Function	Mean deviation and pattern standard deviation of 10-2 Humphrey visual field	3 Months
Secondary	Macular Pigment Optical Density	Macular Pigment Optical Density measured by Mapcat SF	Monthly for 3 months
Secondary	Dermal Carotenoid Levels	Measured by Veggie Meter	Monthly for 3 months
Secondary	Contrast Sensitivity	Measured by Vector Vision CSV-2000	Monthly for 3 months