Augmented Macular Pigment-containing Nutraceutical and Central Visual Function

Phase 4

Withdrawn

• Conditions: Glaucoma; Glaucoma Eye; Glaucoma, Open-Angle
• Interventions: Other: Placebo; Dietary Supplement: Lumega-Z; Drug: Dorzolamide Hcl 2% Oph Soln

• Registration Number: NCT04676126
• Lead Sponsor: University of the Incarnate Word

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.

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Study Start: 2021-05
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Dorzolamide Hcl 2% Oph Soln	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.
Placebo	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.
Experimental	Lumega-Z	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.

Primary Outcome Measures

Name	Time	Method
Pericentral Visual Function	3 Months	Mean deviation and pattern standard deviation of 10-2 Humphrey visual field

Secondary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density	Monthly for 3 months	Macular Pigment Optical Density measured by Mapcat SF
Dermal Carotenoid Levels	Monthly for 3 months	Measured by Veggie Meter
Contrast Sensitivity	Monthly for 3 months	Measured by Vector Vision CSV-2000

Trial Locations

Locations (1)

Ophtalmology Clinic of William E Sponsel; 🇺🇸 San Antonio, Texas, United States