Trial Outcomes & Findings for Macular Pigment and Glare Disability (NCT NCT00909090)

Results Overview

optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

every three months for one year; 12-month measure reported.

Results posted on

2020-07-13

Participant Flow

Recruitment was initiated in May, 2009. The enrollment period was rolling and lasted for 30 months. Enrollment closed in November, 2011. Participants were recruited from the local Athens, Clarke-County community and the University of Georgia student population.

Key events: Telephone screening to confirm eligibility Enrollment Randomization

Participant milestones

Participant milestones
Measure	Intervention 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Placebo visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Overall Study STARTED	53	56
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Placebo visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Overall Study Lost to Follow-up	17	17

Baseline Characteristics

Macular Pigment and Glare Disability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	12 mg Lutein + Zeaxanthin n=53 Participants 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Visually Identical Placebo n=56 Participants visually identical placebo Placebo: Visually identical placebo, taken once daily for one year	Total n=109 Participants Total of all reporting groups
Age, Continuous	23.7 years STANDARD_DEVIATION 4.61 • n=93 Participants	22.7 years STANDARD_DEVIATION 3.32 • n=4 Participants	23.2 years STANDARD_DEVIATION 3.97 • n=27 Participants
Sex/Gender, Customized Gender · Male	22 Participants n=93 Participants	22 Participants n=4 Participants	44 Participants n=27 Participants
Sex/Gender, Customized Gender · Female	31 Participants n=93 Participants	34 Participants n=4 Participants	65 Participants n=27 Participants
Region of Enrollment United States	53 participants n=93 Participants	56 participants n=4 Participants	109 participants n=27 Participants
BMI	22.9 kg/cm^2 STANDARD_DEVIATION 2.45 • n=93 Participants	22.8 kg/cm^2 STANDARD_DEVIATION 2.66 • n=4 Participants	22.85 kg/cm^2 STANDARD_DEVIATION 2.56 • n=27 Participants
Iris Darkness	2.90 units on a scale STANDARD_DEVIATION 1.31 • n=93 Participants	2.81 units on a scale STANDARD_DEVIATION 1.27 • n=4 Participants	2.86 units on a scale STANDARD_DEVIATION 1.29 • n=27 Participants

PRIMARY outcome

Timeframe: every three months for one year; 12-month measure reported.

Population: Participants who completed all four measurements

optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity

Outcome measures

Outcome measures
Measure	Luten + Zeaxanthin n=36 Participants 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Placebo n=39 Participants visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Macular Pigment Optical Density	0.54 optical density Standard Deviation 0.10	0.42 optical density Standard Deviation 0.10

SECONDARY outcome

Timeframe: 12-month data point only

light energy needed to obscure or veil a visual target; calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.

Outcome measures

Outcome measures
Measure	Luten + Zeaxanthin n=36 Participants 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Placebo n=39 Participants visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Glare Disability	1.81 log relative energy Standard Deviation 0.10	1.83 log relative energy Standard Deviation 0.11

SECONDARY outcome

Timeframe: improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)

amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target

Outcome measures

Outcome measures
Measure	Luten + Zeaxanthin n=36 Participants 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Placebo n=39 Participants visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Photostress Recovery Time	10.5 seconds Standard Deviation 7.5	4.5 seconds Standard Deviation 6.0

SECONDARY outcome

Timeframe: 12-month data point only

amount of short-wave light energy necessary to obscure of veil a visual target, calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.

Outcome measures

Outcome measures
Measure	Luten + Zeaxanthin n=36 Participants 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	Placebo n=39 Participants visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Heterochromatic Contrast Sensitivity	1.21 log relative energy Standard Deviation 0.14	1.16 log relative energy Standard Deviation 0.10

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Billy Hammond, Principal Investigator

University of Georgia

Phone: (706) 54204812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place