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

NCT07355725 | Completed DMC

• 1 other identifier: BIAG-CSP-052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive

Outcome Measures

Primary Outcomes (1)

• Change in MPOD

  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 Outcomes (2)

• Change in visual processing speed

  6 months

• Change in contrast sensitivity

  6 months

Study Arms (2)

Lutemax 2020 gummies

EXPERIMENTAL

Administered once a day for the duration of 6 month.

Dietary Supplement: Lutemax 2020 gummies

Placebo Gummies

PLACEBO COMPARATOR

Administered once a day for the duration of 6 month.

Other: Placebo

Interventions

Lutemax 2020 gummies DIETARY_SUPPLEMENT

Lutein 10 mg \& Zeaxanthin isomers 2 mg

Lutemax 2020 gummies

Placebo OTHER

Placebo gummies

Placebo Gummies

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children (Male/female) of ≥5 and ≤12 years of age
• Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height
• Participants with screen time i.e., exposure to digital devices for minimum 4 hours per day
• Participants who agree to maintain their usual dietary habits throughout the trial period.
• Participants who agree to maintain their usual level of activity throughout the trial period
• 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.
• 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

You may not qualify if:

• Participants ˂ 5 or ˃ 12 years of age
• Participants having hypersensitivity or history of allergy to the study product or any of its ingredients
• 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
• 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
• Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries
• 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
• Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry
• Participant with any other condition, which as per the investigator would jeopardize the outcome of the trial
• Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

Sponsors & Collaborators

• Bioagile Therapeutics Pvt. Ltd.: lead

Study Sites (1)

Sanjeevini Netralaya

Bangalore, Karnataka, 560001, India

Location

Study Officials

• Divya Chandradhara, Msc

  divya@bioagiletherapeutics.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: January 21, 2026
• Study Start: July 21, 2022
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)