Clinical trial NCT06574685: Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity
Official title: Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Immunity
Keywords: Lutein
Zeaxanthin
Elderberry
Ocular Health
Immunity
Lead sponsor: Ecolite Group
Sponsor class: INDUSTRY
Collaborators: name: UCSI University
First posted: 2024-08-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group intervention and one group placebo, consumption of supplements for 20 days.
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Ocular Health
timeFrame: 20 days
measure: Ocular Health
timeFrame: 20 days
measure: Immunity
timeFrame: 20 days
measure: Immunity
timeFrame: 20 days
Secondary outcomes:
measure: Lutein and zeaxanthin intakes
timeFrame: 20 days
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: UCSI University
state: Kuala Lumpur
Study officials:
References:
citation: 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.
citation: 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.
citation: Verster JC, Kraneveld AD, Garssen J. The Assessment of Immune Fitness. J Clin Med. 2022 Dec 20;12(1):22. doi: 10.3390/jcm12010022.
citation: 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.