NCT03959592

Macular Pigment and Visual Performance in Glaucoma Patients

Terminated Phase 1, PHASE2 Results posted Last updated 3 January 2023

What this trial tests

Phase 1, PHASE2 trial testing Lutein, zeaxanthin and mesozeaxanthin in Glaucoma in 8 participants. Terminated before completion.

Timeline

21 August 2019

Primary endpoint
9 November 2021

9 November 2021

Quick facts

Lead sponsor	Felipe Medeiros, MD
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	8
Start date	21 August 2019
Primary completion	9 November 2021
Estimated completion	9 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Lutein, zeaxanthin and mesozeaxanthin — full drug profile →
• Placebo

Conditions studied

• Glaucoma — all drugs for Glaucoma →

Sponsor

Felipe Medeiros, MD — full company profile →

Who can join

Adults 18 to 75, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Contrast Sensitivity Primary · Baseline to 6 months

Contrast sensitivity is the ability to detect subtle differences in shading and patterns. In temporal contrast sensitivity, a spatially homogeneous disc whose luminance varies sinusoidally over time is presented. Its temporal frequency is measured as the maximum number of cycles in a second (Hz) at which the flickering is perceived by the patient.

Group	Value	95% CI
Lutein, Zeaxanthin and Mesozeaxanthin	3.44	± 4.83
Placebo	-0.23	± 1.90

Change in the Macular Pigment Optical Density Primary · Baseline to 6 months

Accumulation of the macular carotenoids (lutein, zeaxanthin, and mesozeaxanthin) occurs in the central retina, and is characterized by its optical density (the ability of the pigment to absorb light). Optical density equals the log to the base 10 of the reciprocal of the transmittance.

Group	Value	95% CI
Lutein, Zeaxanthin and Mesozeaxanthin	0.06	± 0.06
Placebo	0.02	± 0.03

Change in Vision in Glare as Measured by Percentage of Contrast Secondary · Baseline to 6 months

Visual performance, especially contrast sensitivity, is greatly decreased by the presence of glare. Range 0% (white on white) to 100% (black on white) contrast.

Group	Value	95% CI
Lutein, Zeaxanthin and Mesozeaxanthin	0
Placebo	48

Change in the Quality of Life by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Secondary · Baseline to 6 months

The NEI VFQ-25 is a 25-question visual function quality questionnaire. Values are assigned from 0 to 100 according to the answers to 25 items. Higher values represent a better outcome.

Group	Value	95% CI
Lutein, Zeaxanthin and Mesozeaxanthin	11.2	± 10.8
Placebo	11.0	± 14.2

Change in Visual Field Assessment Secondary · Baseline to 6 months

A visual field assessment tests the sensitivity of regions across the retina that correspond to points in the visual field. Mean deviation (MD) reflects the overall depression (deviation from normal values) of the field in dB.

Group	Value	95% CI
Lutein, Zeaxanthin and Mesozeaxanthin	0.06	± 0.59
Placebo	-0.36	± 1.65

Sponsor's own description

The purpose of this study is to determine cross-sectional relationships between macular pigment optical density (MPOD) and visual performance in glaucoma. Additionally, the investigators wish to determine the effect of lutein, zeaxanthin, and mesozeaxanthin supplementation on MPOD and visual performance in glaucoma patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Inherited Retinal Dystrophies: Role of Oxidative Stress and Inflammation in Their Physiopathology and Therapeutic Implications.
   Pinilla I, Maneu V, Campello L, Fernández-Sánchez L, et al · · 2022 · cited 30× · PMID 35739983 · DOI 10.3390/antiox11061086