Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity

NCT06574685 | Completed

• 1 other identifier: ECO0001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dry Eye Disease; Immunity

Keywords

Lutein; Zeaxanthin; Elderberry; Ocular Health; Immunity

Outcome Measures

Primary Outcomes (4)

• Ocular Health

  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

  20 days

• Ocular Health

  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.

  20 days

• Immunity

  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).

  20 days

• Immunity

  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.

  20 days

Secondary Outcomes (1)

• Lutein and zeaxanthin intakes

  20 days

Study Arms (2)

Twinkle Eyez Supplementation

EXPERIMENTAL

Dietary Supplement: Twinkle Eyez Supplementation

Placebo control

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

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.

Twinkle Eyez Supplementation

Placebo DIETARY_SUPPLEMENT

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

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ecolite Group: lead
• UCSI University: collaborator

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (4)

• Cena H, Roggi C, Turconi G. Development and validation of a brief food frequency questionnaire for dietary lutein and zeaxanthin intake assessment in Italian women. Eur J Nutr. 2008 Feb;47(1):1-9. doi: 10.1007/s00394-007-0689-0. Epub 2007 Dec 28.

  PMID: 18165856 BACKGROUND

• Miller KL, Walt JG, Mink DR, Satram-Hoang S, Wilson SE, Perry HD, Asbell PA, Pflugfelder SC. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010 Jan;128(1):94-101. doi: 10.1001/archophthalmol.2009.356.

  PMID: 20065224 BACKGROUND

• Verster JC, Kraneveld AD, Garssen J. The Assessment of Immune Fitness. J Clin Med. 2022 Dec 20;12(1):22. doi: 10.3390/jcm12010022.

  PMID: 36614822 BACKGROUND

• Frings A, Ziaei M, Lundstrom M, Allan BD. The Vision Correction Questionnaire: an electronic patient-reported outcome measure for refractive surgery. J Cataract Refract Surg. 2022 Dec 1;48(12):1427-1432. doi: 10.1097/j.jcrs.0000000000001018.

  PMID: 35858627 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To maintain blinding, placebo supplements were identical in appearance to the intervention supplements, and investigators remained unaware of the participants' group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group intervention and one group placebo, consumption of supplements for 20 days.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: July 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

MY (1)