Numerous clinical trials evaluate zeaxanthin, predominantly focusing on systemic lipid parameters and ocular conditions such as age-related macular degeneration, macular holes, epiretinal membranes, and proliferative diabetic retinopathy. Spanning Phase 1 through Phase 3 alongside non-applicable dietary interventions, these studies encompass recruiting, completed, terminated, and withdrawn statuses to assess macular pigment optical density and retinal physiology. Research is primarily sponsored by academic institutions and government organizations, including the University of California, Davis, Tufts University, and the United States Department of Agriculture.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05232409 | RECRUITING | Cancer Metastatic; Metastatic Solid Tumor |
Valley Health System |
2022-04-17 | PHASE1 |
| NCT06965426 | RECRUITING | Macular Degenerative Disease |
Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, |
2025-06-01 | |
| NCT06489873 | RECRUITING | Cognitive Performance; Age-Related Macular Degeneration; Bone Loss |
Texas A&M University |
2024-02-07 | |
| NCT06237127 | Recruiting | Age-Related Macular Degeneration |
University of California Davis|United States Department of Agriculture (USDA) |
2024-04-29 | Not Applicable |
| NCT07355725 | COMPLETED | Cognitive |
Bioagile Therapeutics Pvt. Ltd. |
2022-07-21 | |
| NCT05283941 | Recruiting | Macular Degeneration|Retinal Degeneration|Retinal Diseases|Eye Diseases |
Tufts University|American Pistachio Growers |
2022-06-10 | Not Applicable |
| NCT06391411 | COMPLETED | Age-Related Macular Degeneration |
Azienda Ospedaliero-Universitaria Careggi |
2021-03-01 | |
| NCT05267522 | Completed | Hypercholesterolemia|Hyperlipidemias|Physical Inactivity|Diet Healthy |
University of South Australia|American Egg Board |
2022-03-01 | Not Applicable |
| NCT06358352 | COMPLETED | Osteogenesis |
Mansoura University |
2021-10-01 | |
| NCT03750968 | COMPLETED | Nutrient Deficiency; Pregnancy Related |
Paul S. Bernstein |
2019-09-26 | PHASE2 |
| NCT03959592 | TERMINATED | Glaucoma |
Felipe Medeiros, MD |
2019-08-21 | PHASE1; PHASE2 |
| NCT04460365 | COMPLETED | Glaucoma, Open-Angle |
Centre for Eye Research Ireland |
2017-10-01 | |
| NCT03983525 | COMPLETED | Macular Pigment Optical Density |
University of California, Davis |
2019-06-10 | |
| NCT03340103 | WITHDRAWN | Antioxidant Role of the Lutein in Preterm Newborn |
Sooft Italia |
2018-10-11 | |
| NCT02136303 | UNKNOWN | Changes in Macular Pigment Optical Density |
University of Jena |
2015-02 | |
| NCT02200263 | COMPLETED | Ocular Albinism (OA); Oculocutaneous Albinism (OCA) |
Johns Hopkins University |
2014-11 | |
| NCT02023645 | UNKNOWN | Mild Cognitive Impairment |
University of Georgia |
2012-01 | |
| NCT01404845 | COMPLETED | Exudative Age-related Macular Degeneration |
Affordance |
2011-09 | |
| NCT02017418 | COMPLETED | Behavior and Behavior Mechanisms |
University of Georgia |
2012-02 | |
| NCT02113254 | TERMINATED | Age Macular Degeneration |
University Hospital, Bordeaux |
2014-02 | |
| NCT01627977 | COMPLETED | Epiretinal Membrane; Macular Hole; Proliferative Diabetic Retinopathy |
Federal University of São Paulo |
2012-10 | PHASE3 |
| NCT01621789 | COMPLETED | Cataract |
Federal University of São Paulo |
2012-06 | PHASE3 |
| NCT01648660 | COMPLETED | Age Related Maculopathy |
University of Jena |
2009-05 | |
| NCT00909090 | COMPLETED | Vision, Entoptic |
University of Georgia |
2009-05 | |
| NCT00345176 | COMPLETED | Age-related Macular Degeneration; Cataract |
National Eye Institute (NEI) |
2006-09 | PHASE3 |
| NCT01528605 | COMPLETED | Age-related Macular Degeneration |
Peking University |
2010-06 | |
| NCT01048476 | UNKNOWN | Age-related Macular Degeneration |
Peking University |
2009-09 | PHASE1; PHASE2 |
| NCT00763659 | COMPLETED | Age Related Maculopathy |
University of Jena |
2008-05 | |
| NCT00596024 | TERMINATED | Alzheimer's Disease |
Oregon Health and Science University |
2007-12 | PHASE2 |
| NCT00564902 | COMPLETED | Age Related Macular Degeneration; Cognition Disorders |
Chrysantis, Inc. |
2007-11 | |
| NCT00672230 | COMPLETED | Lactation |
Oregon Health and Science University |
2005-08 | |
| NCT00527553 | COMPLETED | Age-related Macular Degeneration |
Maastricht University Medical Center |
2007-10 | |
| NCT00121589 | COMPLETED | Macular Degeneration |
National Eye Institute (NEI) |
2005-07-14 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-06-05)
Check the
Zeaxanthin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.