To Evaluate the Efficacy of Lutemax 2020 on Vision and Cognitive Performance in Health Children.

January 13, 2026 updated by: Bioagile Therapeutics Pvt. Ltd.

A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Children

To address the detrimental effects of the sudden rise in the use of digital devices leading to increased screen time, the present study will assess the efficacy of macular carotenoid supplementation Lutemax 2020 in young children

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Extensive exposure to digital devices like laptops, smart phones, etc.is a result of advanced technology in today's modern world. Especially, the children of 21st century are avid users of technology. The precipitous rise in the use of digital devices has raised concerns about potentially deleterious health effects due to increased screen time and associated exposure to short wavelength blue light. Adverse effects include damage to retina, physical health and cognitive performance. To adapt to this change, a diet-derived, blue-absorbing pigment, composed of the dietary carotenoids lutein (L) and zeaxanthin (Z), which are found in relatively high concentrations in leafy-green vegetables, and along with the Z isomer mesozeaxanthin (MZ), are deposited in rich concentrations in the macular retina. They play an important role in protecting the retina from cumulative damage that can result in visual and cognitive detriments and further progress to Age-related Macular Degeneration (AMD). To address the detrimental effects of the sudden rise in the use of digital devices leading to increased screen time, the present study will assess the efficacy of macular carotenoid supplementation Lutemax 2020 in young children. Efficacy will be evaluated based on the effect of Lutemax 2020 on MPOD and other visual parameters, visual processing speed, contrast sensitivity along with cognitive performance parameters in comparison with the baseline readings. Serum parameters such as BDNF, L and Z concentrations will also be assessed and compared with the baseline levels.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560001
        • Sanjeevini Netralaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children (Male/female) of ≥5 and ≤12 years of age
  2. Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height
  3. Participants with screen time i.e., exposure to digital devices for minimum 4 hours per day
  4. Participants who agree to maintain their usual dietary habits throughout the trial period.
  5. Participants who agree to maintain their usual level of activity throughout the trial period
  6. Participants demonstrates understanding of the study and willingness to participate as evidenced by participant's parents or legally authorized representative's by giving voluntary written informed consent.
  7. Participants willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study

Exclusion Criteria:

  1. Participants ˂ 5 or ˃ 12 years of age
  2. Participants having hypersensitivity or history of allergy to the study product or any of its ingredients
  3. Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator
  4. Participants having a current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
  5. Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries
  6. Participants consuming carotenoid supplements including lutein and zeaxanthin, anti-oxidant supplements, iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week, in the recommended dosage) in the last 1 month prior to screening visit
  7. Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry
  8. Participant with any other condition, which as per the investigator would jeopardize the outcome of the trial
  9. Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lutemax 2020 gummies
Administered once a day for the duration of 6 month.
Dietary supplement: Lutemax 2020 gummies
Lutein 10 mg & Zeaxanthin isomers 2 mg
Placebo Comparator: Placebo Gummies
Administered once a day for the duration of 6 month.
Other: Placebo
Placebo gummies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in MPOD
Time Frame: 6 months
Mean change in Macular Pigment Optical Density (MPOD) from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in visual processing speed
Time Frame: 6 months
Mean change in visual processing speed from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days)
6 months
Change in contrast sensitivity
Time Frame: 6 months
Mean change in contrast sensitivity from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bioagile Therapeutics Pvt. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Divya Chandradhara, Msc, divya@bioagiletherapeutics.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIAG-CSP-052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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