The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism

NCT02200263 | Completed DMC

• 1 other identifier: NA_00088335
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo (no treatment) gel pill over the period of 12 months, with study visits approximately every 3 months for the first year and a final visit 18 months after enrollment.

Conditions

Ocular Albinism (OA); Oculocutaneous Albinism (OCA)

Keywords

ocular albinism (OA); oculocutaneous albinism (OCA); macular pigment; visual function

Outcome Measures

Primary Outcomes (1)

• Macular pigment optical density (MPOD)

  MPOD will be measured at baseline and follow-up. MPOD will be evaluated psychophysically using the QuantifEye device (ZeaVision), optically using the MPOD module of the Heidelberg Spectralis multicolor imaging device, and by quantitative fundus autofluorescence (FAF) using the Heidelberg Spectralis multicolor imaging device

  12 months

Secondary Outcomes (5)

• Contrast acuity

  12 months

• Visual field, fixation and central retinal sensitivity

  12 months

• Bioavailability profile of Lutein and Zeaxanthin

  12 months

• Evaluation of the diversity of microstructural central retinal abnormalities

  12 months

• Best Corrected Visual Acuity (BCVA)

  12 months

Study Arms (2)

Lutein plus Zeaxanthin

EXPERIMENTAL

Participants randomized to this arm will receive 20 mg of Lutein (L) plus 20 mg of Zeaxanthin (Z) per day: Two pills (10 mg L+ 10 mg Z per pill) for the duration of one year.

Dietary Supplement: Lutein plus Zeaxanthin

Placebo softgels

PLACEBO COMPARATOR

Participants randomized to this arm will receive two pills per day of placebo-gels corresponding to the active compound in look and feel for the duration of one year

Dietary Supplement: Placebo

Interventions

Lutein plus Zeaxanthin DIETARY_SUPPLEMENT

dose: two softgels once a day with a meal

Also known as: EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)

Lutein plus Zeaxanthin

Placebo DIETARY_SUPPLEMENT

two softgels once-daily with a meal

Also known as: placebo softgels

Placebo softgels

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 12 years old and older
• Clinical and/or genetic diagnosis of ocular or oculocutaneous albinism
• Ocular media allowing acceptable visualization of the retina.
• Ocular media allowing acceptable quality of the ocular coherence tomography (OCT) and/or fundus autofluorescence (FAF) scans.
• At least one reliable central macular pigment optical density (MPOD) measurement captured on the enrollment visit in at least one eligible eye
• Best corrected visual acuity of 20/200 or better in one or both eligible eyes (eyes that confirmed to be eligible by the MPOD testing).

You may not qualify if:

• Persons taking lutein and/or zeaxanthin supplements over the past 6 months
• Pregnant or planning to become pregnant
• Evidence of present or past retinal macular condition other than congenital foveal hypoplasia
• History of gastrointestinal disease that would interfere with absorption of lutein and zeaxanthin
• Participation in a clinical trial requiring visual testing or administration of a drug (marketed or investigational) within 60 days before entry in the study (the day informed consent is signed)
• Inability to communicate or cooperate with the investigator due to cognitive impairment or poor general health
• Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study

Sponsors & Collaborators

• Johns Hopkins University: lead
• Clark Charitable Foundation Inc.: collaborator

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287-9277, United States

Location

MeSH Terms

Conditions

Albinism, Ocular; Albinism, Oculocutaneous

Interventions

Lutein; Zeaxanthins

Condition Hierarchy (Ancestors)

Albinism; Eye Diseases, Hereditary; Eye Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Skin Diseases, Genetic; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic 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

Study Officials

• Neil Bressler, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Mary E. Frey

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)