Dry Eye DiseaseNCT06574685
Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity
A study testing Twinkle Eyez Supplementation in people with Dry Eye Disease and Immunity, run by Ecolite Group at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease, Immunity
- What is being tested?
- Twinkle Eyez Supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Twinkle Eyez Supplementation, Placebo
- Keywords
- Lutein, Zeaxanthin, Elderberry, Ocular Health, Immunity
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twinkle Eyez SupplementationDietary 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.
PlaceboDietary supplement
The placebo supplement was identical in composition but excluded the active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Twinkle Eyez Supplementation | Experimental | Not described Receives: Dietary Supplement: Twinkle Eyez Supplementation |
| Placebo control | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 20 days
Secondary outcomes (1)
Lutein and zeaxanthin intakes
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.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group intervention and one group placebo, consumption of supplements for 20 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecolite Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574685
- Sponsor's protocol ID
- ECO0001
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional documents including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following publication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.
Publications
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.
PubMed 18165856Miller 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.
PubMed 20065224Verster JC, Kraneveld AD, Garssen J. The Assessment of Immune Fitness. J Clin Med. 2022 Dec 20;12(1):22. doi: 10.3390/jcm12010022.
PubMed 36614822Frings 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.
PubMed 35858627
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity
- ClinicalTrials.gov ID
- NCT06574685
- Acronym / sponsor ID
- ECO0001
- Conditions
- Dry Eye Disease, Immunity
- Keywords
- Lutein, Zeaxanthin, Elderberry, Ocular Health, Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ecolite GroupIndustry (pharma, biotech, devices)
- Collaborators
- UCSI University
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One group intervention and one group placebo, consumption of supplements for 20 days.
| Arm | Type | Receives |
|---|---|---|
| Twinkle Eyez Supplementation | Experimental | Dietary Supplement: Twinkle Eyez Supplementation |
| Placebo control | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twinkle Eyez SupplementationThe 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. | Dietary supplement | Twinkle Eyez Supplementation |
| PlaceboThe placebo supplement was identical in composition but excluded the active ingredients. | Dietary supplement | Placebo control |
Primary outcome
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
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.
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).
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.
1 secondary outcome
Lutein and zeaxanthin intakes
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 18165856Cena 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.
- Background: PubMed 20065224Miller 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.
- Background: PubMed 36614822Verster JC, Kraneveld AD, Garssen J. The Assessment of Immune Fitness. J Clin Med. 2022 Dec 20;12(1):22. doi: 10.3390/jcm12010022.
- Background: PubMed 35858627Frings 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.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional documents including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following publication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twinkle Eyez Supplementation in people with Dry Eye Disease and Immunity, run by Ecolite Group at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Health (time frame: 20 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06574685, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.