Macular Pigment and Visual Performance in Glaucoma Patients

NCT03959592 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: Pro00093041
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Change in Contrast Sensitivity

  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.

  Baseline to 6 months

• Change in the Macular Pigment Optical Density

  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.

  Baseline to 6 months

Secondary Outcomes (5)

• Change in the Speed of Dark Adaptation

  Baseline to 6 months

• Change in Vision in Glare as Measured by Percentage of Contrast

  Baseline to 6 months

• Change in the Quality of Life by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25)

  Baseline to 6 months

• Change in Visual Field Assessment

  Baseline to 6 months

• Change in the Point-spread Function

  Baseline to 6 months

Study Arms (2)

Lutein, zeaxanthin and mesozeaxanthin

ACTIVE COMPARATOR

Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain 22 mg total of the carotenoids lutein (10 mg), zeaxanthin (2 mg), and mesozeaxanthin (10 mg).

Drug: Lutein, zeaxanthin and mesozeaxanthin

Placebo

PLACEBO COMPARATOR

Patients will be asked to consume 1 pill daily with a meal, for six months. The pills will contain only sunflower oil (placebo).

Other: Placebo

Interventions

Lutein, zeaxanthin and mesozeaxanthin DRUG

The intervention will involve supplementation with the macular carotenoids (1 pill daily with a meal containing lutein, zeaxanthin, mesozeaxanthin) for six months, to determine the effects on visual performance in glaucoma patients.

Also known as: macular carotenoids

Lutein, zeaxanthin and mesozeaxanthin

Placebo OTHER

This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• glaucoma diagnosis: To be considered glaucomatous, patients will be required to have: (1) history of elevated intraocular pressure (IOP; over 21 mmHg); (2) at least two consecutive and reliable standard automated perimetry (SAP) examinations with either a pattern standard deviation (PSD) outside the 95% normal limits or a glaucoma hemifield test (GHT) result outside the 99% normal limits; and/or glaucomatous optic neuropathy.
• between the ages of 18 and 75 years,
• must be able and willing to provide signed informed consent and follow study instructions.

You may not qualify if:

• no systemic disease, no other ocular disease

Sponsors & Collaborators

• Felipe Medeiros, MD: lead
• Heidelberg Engineering GmbH: collaborator
• MacuHealth: collaborator
• Industrial Orgánica S.A. de C.V.: collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Lutein; Zeaxanthins

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Alessandro Jammal, M.D., Ph.D.
• Organization: Duke University

alessandro.jammal@duke.edu

919-684-0202

Study Officials

• Felipe A Medeiros, MD, PhD

  Duke Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Ophthalmology

Model Details: Double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 22, 2019
• Study Start: August 21, 2019
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: January 3, 2023
• Results First Posted: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)