Investigation of Macular Pigment Augmentation on Dark Adaptation

This study has been terminated.
(Study terminated: Recruitment delay due to equipment malfunction)
Sponsor:
Collaborator:
ZeaVision, Inc.
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00478439
First received: May 22, 2007
Last updated: October 26, 2010
Last verified: October 2010

May 22, 2007
October 26, 2010
December 2007
September 2009   (final data collection date for primary outcome measure)
Dark Adaptation [ Time Frame: Measured 3 times over 8 months ] [ Designated as safety issue: No ]
Dark Adaptation [ Time Frame: Measured 3 times over 8 months ]
Complete list of historical versions of study NCT00478439 on ClinicalTrials.gov Archive Site
Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ] [ Designated as safety issue: No ]
Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ]
Not Provided
Not Provided
 
Investigation of Macular Pigment Augmentation on Dark Adaptation
Investigation of Macular Pigment Augmentation on Dark Adaptation

The study will evaluate whether taking a nutritional supplement designed to increase macular pigment in the eye can improve a person's ability to adjust to darkness. Patients will be assigned to take either a placebo or nutritional supplement for 8 months. Vision will be assessed at baseline, 4 months, and 8 months.

The study design is a randomized, double-blinded, placebo-controlled intervention study that will evaluate whether macular pigment augmentation improves the speed of dark adaptation. Two groups of participants will be enrolled, old adults with normal vision and early age-related macular degeneration patients. Macular pigment will be augmented using EyePromise RESTORE (ZeaVision, Inc). EyePromise RESTORE is a nutritional supplement that has been found to increase macular pigment levels in some users. Macular pigment level and the speed of dark adaptation (how fast a person adjusts to the dark) will be assessed at baseline, 4-months, and 8-months. Fundus appearance will be assessed at baseline and 8-months follow-up.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Aging
  • Age-Related Macular Degeneration
  • Dietary Supplement: ZeaVision EyePromise Restore
    Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,
  • Dietary Supplement: Multivitamin
    Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,
Placebo Comparator: Placebo Comparator
Interventions:
  • Dietary Supplement: ZeaVision EyePromise Restore
  • Dietary Supplement: Multivitamin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
October 2010
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 60 to 80 years old
  • < +- 4.00 diopters spherical equivalent
  • normal eye health or early age-related macular degeneration

Exclusion Criteria:

  • neurological conditions that can impair vision
  • diabetes
Both
60 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00478439
F070410002
No
Leo P. Semes, O.D./Principal Investigator, UAB School of Optometry
University of Alabama at Birmingham
ZeaVision, Inc.
Principal Investigator: Leo P Semes, O.D. University of Alabama at Birmingham
University of Alabama at Birmingham
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP