Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity

Ecolite Group

Status: Completed

Conditions: Immunity; Dry Eye Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Twinkle Eyez Supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06574685

ECO0001

Details and patient eligibility

About

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).

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Twinkle Eyez Supplementation

Experimental group

Treatment:

Dietary Supplement: Twinkle Eyez Supplementation

Placebo control

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo