EyeNCT06412393
Evaluation of Eye Health Benefits of Black Tomato Extract
A study testing Black tomato extract powder in people with Eye and High Myopia, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
Verification of the efficacy of black tomato extract for eye health. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eye, High Myopia
- What is being tested?
- Black tomato extract powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2024to 30 Apr 2025
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than 20 and capable of providing informed consent.
- Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).
- BMI between 22 and 35.
- High myopia population (-5.00 to -9.00D)
Who cannot join
- History of any eye surgery (e.g., strabismus surgery, refractive surgery).
- Presence of systemic diseases affecting the anterior surface of the eye.
- Long-term use of medications affecting the anterior surface of the eye.
Trial locations and contacts
1 site in 1 country.
About this study
Verification of the efficacy of black tomato extract for eye health.
- Conditions
- Eye, High Myopia
- Being tested
- Black tomato extract powder, Placebo powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black tomato extract powderDietary supplement
take 2 packets per day for 8 weeks
Placebo powderDietary supplement
take 2 packets per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo powder | Placebo comparator | Dietary Supplement: Placebo powder Receives: Dietary Supplement: Placebo powder |
| Black tomato extract powder | Experimental | Dietary Supplement: Black tomato extract powder Receives: Dietary Supplement: Black tomato extract powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure Measurement (IOP)
Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg
Measured: Change from Baseline at 8 weeks
Grading of Retinal Vascular Diameter
Measurement of Grading of Retinal Vascular Diameter using a fundus camera.
Measured: Change from Baseline at 8 weeks
Visual Contrast Sensitivity Function
Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions.
Measured: Change from Baseline at 8 weeks
Negative Fusional Vergence (NFV)
Measurement of Negative Fusional Vergence using a phoropter.
Measured: Change from Baseline at 8 weeks
Positive Fusional Vergence (PFV)
Measurement of Positive Fusional Vergence using a phoropter.
Measured: Change from Baseline at 8 weeks
Negative Relative Accommodation (NRA)
Measurement of Negative Relative Accommodation using a phoropter.
Measured: Change from Baseline at 8 weeks
Positive Relative Accommodation (PRA)
Measurement of Positive Relative Accommodation using a phoropter.
Measured: Change from Baseline at 8 weeks
Accommodative Facility
Measurement of Accommodative Facility using a Flipper lens ±2.00D.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (4)
Questionnaire Survey - Ocular Surface Disease Index (OSDI)
The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
Measured: Change from Baseline at 8 weeks
The change of Endothelin-1 (ET-1)
Fasting venous blood will be sampled to measure concentrations of ET-1.
Measured: Change from Baseline at 8 weeks
The change of Tumor necrosis factor-α (TNF-α)
Fasting venous blood will be sampled to measure concentrations of TNF-α.
Measured: Change from Baseline at 8 weeks
Best-corrected visual acuity
Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.
Measured: Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EyeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo-Yie Chen boychen@csmu.edu.tw, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412393
- Sponsor's protocol ID
- CS1-23170
- Status last verified
- Jun 2025
- First submitted
- 3 May 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eye Health Benefits of Black Tomato Extract
- ClinicalTrials.gov ID
- NCT06412393
- Acronym / sponsor ID
- CS1-23170
- Conditions
- Eye, High Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 14 May 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.
Verification of the efficacy of black tomato extract for eye health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo powder | Placebo comparator | Dietary Supplement: Placebo powderDietary Supplement: Placebo powder |
| Black tomato extract powder | Experimental | Dietary Supplement: Black tomato extract powderDietary Supplement: Black tomato extract powder |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 20 and capable of providing informed consent.
- Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).
- BMI between 22 and 35.
- High myopia population (-5.00 to -9.00D)
Key exclusion criteria (3 listed)
- History of any eye surgery (e.g., strabismus surgery, refractive surgery).
- Presence of systemic diseases affecting the anterior surface of the eye.
- Long-term use of medications affecting the anterior surface of the eye.
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 |
|---|---|---|
| Black tomato extract powdertake 2 packets per day for 8 weeks | Dietary supplement | Black tomato extract powder |
| Placebo powdertake 2 packets per day for 8 weeks | Dietary supplement | Placebo powder |
Primary outcome
Intraocular Pressure Measurement (IOP)
Time frame: Change from Baseline at 8 weeks
Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg
Grading of Retinal Vascular Diameter
Time frame: Change from Baseline at 8 weeks
Measurement of Grading of Retinal Vascular Diameter using a fundus camera.
Visual Contrast Sensitivity Function
Time frame: Change from Baseline at 8 weeks
Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions.
Negative Fusional Vergence (NFV)
Time frame: Change from Baseline at 8 weeks
Measurement of Negative Fusional Vergence using a phoropter.
Positive Fusional Vergence (PFV)
Time frame: Change from Baseline at 8 weeks
Measurement of Positive Fusional Vergence using a phoropter.
Negative Relative Accommodation (NRA)
Time frame: Change from Baseline at 8 weeks
Measurement of Negative Relative Accommodation using a phoropter.
Positive Relative Accommodation (PRA)
Time frame: Change from Baseline at 8 weeks
Measurement of Positive Relative Accommodation using a phoropter.
Accommodative Facility
Time frame: Change from Baseline at 8 weeks
Measurement of Accommodative Facility using a Flipper lens ±2.00D.
4 secondary outcomes
Questionnaire Survey - Ocular Surface Disease Index (OSDI)
Time frame: Change from Baseline at 8 weeks
The change of Endothelin-1 (ET-1)
Time frame: Change from Baseline at 8 weeks
The change of Tumor necrosis factor-α (TNF-α)
Time frame: Change from Baseline at 8 weeks
Best-corrected visual acuity
Time frame: Change from Baseline at 8 weeks
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 13 Jun 2025.
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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.
Bo-Yie Chen boychen@csmu.edu.tw principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black tomato extract powder in people with Eye and High Myopia, run by TCI Co., Ltd. at 1 site in Taiwan.
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 3 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 13 Jun 2025. 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 Taiwan. 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?
Intraocular Pressure Measurement (IOP) (time frame: Change from Baseline at 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.