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Completed

NCT Number: NCT06574685

Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity

This is a randomised, double-blind, placebo-controlled study that recruited 110 participants. The objectives of this study are to determine the dietary intake levels of lutein and zeaxanthin among precipitants. In additionally, this study also aimed to determine the efficacy of twinkle eyez supplementation in improving ocular health and immunity. The participant are required to take one sachet of twinkle eyez supplements or placebo for 20 days. The outcomes were assessed by food frequency questionnaire (FFQ), Ocular Surface Disease Index (OSDI), the Immune Status Questionnaire (ISQ), and the Visual Analogue Scale (VAS).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Immunity Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presence of dry eye symptoms
  • age 18 years or older
  • ability to comprehend the study protocol and information provided by the investigators
  • provision of informed consent.

Exclusion criteria

  • ongoing medical treatment for ocular diseases or conditions
  • use of certain medications, including hormone replacement therapy, antidepressants, and treatments for high blood pressure, acne, birth control, and Parkinson's disease
  • history of eye surgery within the past three months
  • pregnancy or lactation

Treatment and study plan

Twinkle Eyez Supplementation

Dietary Supplement

The intervention supplement consisted of marigold extract, zeaxanthin, elderberry extract, bilberry extract, lycopene extract, multivitamin, silicon dioxide, inulin, and dextrose monohydrate, all in powder form and packaged in individual sachets (Twinkle Eyez™; Xmegami, Selangor, Malaysia). Each sachet contained 4.6 mg of lutein and zeaxanthin and 15.4 mg of elderberry extract.

Placebo

Dietary Supplement

The placebo supplement was identical in composition but excluded the active ingredients.

Primary outcomes

  1. Ocular Health

    Time frame: 20 days

    Ocular Surface Disease Index (OSDI) was used to assess the ocular health of participants. The OSDI, a validated 12-item questionnaire, assesses three subcategories: ocular symptoms, vision-related function, and environmental triggers. Each item is rated on a scale from 0 ('none of the time') to 4 ('all of the time'), with the final OSDI score calculated by summing the participant's responses

  2. Ocular Health

    Time frame: 20 days

    Visual Analogue Scale (VAS) was used to assess the ocular health of participants. The VAS is a psychometric measuring instrument designed to document the characteristics of disease-related symptom severity or general wellbeing of an individual, often used in epidemiological and clinical research. Participants were asked to self-rate their current overall ocular health using a 10 cm VAS, where 0 indicated a very poor condition and 10 indicated an excellent condition.

  3. Immunity

    Time frame: 20 days

    Immune Status Questionnaire (ISQ) and Visual Analogue Scale (VAS) was used to assess the immunity status of participants. The ISQ consists of seven items that assess the occurrence of various immune-related symptoms in the past. The total ISQ score was recoded onto a scale from 0 (very poor) to 10 (excellent).

  4. Immunity

    Time frame: 20 days

    Visual Analogue Scale (VAS) was used to assess the immunity status of participants. The VAS is a psychometric measuring instrument designed to document the characteristics of disease-related symptom severity or general wellbeing of an individual, often used in epidemiological and clinical research. Participants were asked to self-rate their current overall immunity status using a 10 cm VAS, where 0 indicated a very poor condition and 10 indicated an excellent condition.

Secondary outcomes

  1. Lutein and zeaxanthin intakes

    Time frame: 20 days

    Dietary intakes of lutein and zeaxanthin over the previous six months were assessed using a validated, simplified food frequency questionnaire (FFQ) tailored to include 30 food items known for their lutein and zeaxanthin content (1). For each food item, a specific serving size was provided, and participants reported their consumption frequency in terms of 'never' or the number of occasions per day, week, or month, as appropriate. The dietary intake of lutein and zeaxanthin was then calculated based on values from the United States Department of Agriculture-National Cancer Institute Carotenoids Database.

Sponsors and collaborators

Lead sponsor

Ecolite Group

Industry

Collaborators

  • UCSI University

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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