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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 22, 2007

Last Updated Date

October 26, 2010

Start Date ^ICMJE

December 2007

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dark Adaptation [ Time Frame: Measured 3 times over 8 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Dark Adaptation [ Time Frame: Measured 3 times over 8 months ]

Change History

Complete list of historical versions of study NCT00478439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Macular Pigment Density [ Time Frame: Measured 3 times over 8 months ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Investigation of Macular Pigment Augmentation on Dark Adaptation

Official Title ^ICMJE

Investigation of Macular Pigment Augmentation on Dark Adaptation

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Aging
Age-Related Macular Degeneration

Intervention ^ICMJE

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,

Study Arm (s)

Placebo Comparator: Placebo Comparator

Interventions:

Dietary Supplement: ZeaVision EyePromise Restore
Dietary Supplement: Multivitamin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

60 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00478439

Other Study ID Numbers ^ICMJE

F070410002

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Leo P. Semes, O.D./Principal Investigator, UAB School of Optometry

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

ZeaVision, Inc.

Investigators ^ICMJE

Principal Investigator:

Leo P Semes, O.D.

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

October 2010

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

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