AgingPhase 4NCT00478439
Investigation of Macular Pigment Augmentation on Dark Adaptation
A Phase 4 study testing ZeaVision EyePromise Restore and Multivitamin in people with Aging and Age-Related Macular Degeneration, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Age-Related Macular Degeneration
- What is being tested?
- ZeaVision EyePromise Restore and Multivitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 to 80 years old
- < +- 4.00 diopters spherical equivalent
- normal eye health or early age-related macular degeneration
Who cannot join
- neurological conditions that can impair vision
- diabetes
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aging, Age-Related Macular Degeneration
- Being tested
- ZeaVision EyePromise Restore, Multivitamin
- Keywords
- aging, age-related macular degeneration, macular pigment, dark adaptation
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZeaVision EyePromise RestoreDietary supplement
Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, Zeaxanthin 8mg,mixed tocopherols 6mg, lutein 4mg,
MultivitaminDietary supplement
Vitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg,
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Not described Receives: Dietary Supplement: ZeaVision EyePromise Restore; Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dark Adaptation
Measured: Measured 3 times over 8 months
Secondary outcomes (1)
Macular Pigment Density
Measured: Measured 3 times over 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2009
- Study completionOct 2010
Why it stopped: Study terminated: Recruitment delay due to equipment malfunction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- ZeaVision, Inc.
- Investigators
- Leo P Semes, O.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478439
- Sponsor's protocol ID
- F070410002
- Status last verified
- Oct 2010
- First submitted
- 22 May 2007
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Macular Pigment Augmentation on Dark Adaptation
- ClinicalTrials.gov ID
- NCT00478439
- Acronym / sponsor ID
- F070410002
- Conditions
- Aging, Age-Related Macular Degeneration
- Keywords
- aging, age-related macular degeneration, macular pigment, dark adaptation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated: Recruitment delay due to equipment malfunction
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- ZeaVision, Inc.
- Study start
- Dec 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Dietary Supplement: ZeaVision EyePromise Restore, Dietary Supplement: Multivitamin |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 to 80 years old
- < +- 4.00 diopters spherical equivalent
- normal eye health or early age-related macular degeneration
Key exclusion criteria (2 listed)
- neurological conditions that can impair vision
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZeaVision EyePromise RestoreVitamin 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 | Placebo Comparator |
| MultivitaminVitamin C 120mg, Vitamin E 60IU, Zinc 15mg, Fish Oil 250mg, Omega 3 125mg, Alphaliploic acid 10mg, mixed tocopherols 6mg, lutein 4mg, | Dietary supplement | Placebo Comparator |
Primary outcome
Dark Adaptation
Time frame: Measured 3 times over 8 months
1 secondary outcome
Macular Pigment Density
Time frame: Measured 3 times over 8 months
Results and safety
The study was stopped early (reason given: Study terminated: Recruitment delay due to equipment malfunction). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leo P Semes, O.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ZeaVision EyePromise Restore and Multivitamin in people with Aging and Age-Related Macular Degeneration, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated: Recruitment delay due to equipment malfunction). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dark Adaptation (time frame: Measured 3 times over 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2010.