Evaluation of Eye Health Benefits of Black Tomato Extract

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06412393

Enrollment

Registered

2024-05-14

Start date

2024-04-01

Completion date

2025-04-30

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye, High Myopia

Brief summary

Verification of the efficacy of black tomato extract for eye health.

Interventions

DIETARY_SUPPLEMENTBlack tomato extract powder

take 2 packets per day for 8 weeks

DIETARY_SUPPLEMENTPlacebo powder

take 2 packets per day for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Accommodative Facility	Change from Baseline at 8 weeks	Measurement of Accommodative Facility using a Flipper lens ±2.00D.
Negative Fusional Vergence (NFV)	Change from Baseline at 8 weeks	Measurement of Negative Fusional Vergence using a phoropter.
Positive Fusional Vergence (PFV)	Change from Baseline at 8 weeks	Measurement of Positive Fusional Vergence using a phoropter.
Negative Relative Accommodation (NRA)	Change from Baseline at 8 weeks	Measurement of Negative Relative Accommodation using a phoropter.
Positive Relative Accommodation (PRA)	Change from Baseline at 8 weeks	Measurement of Positive Relative Accommodation using a phoropter.
Intraocular Pressure Measurement (IOP)	Change from Baseline at 8 weeks	Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg
Grading of Retinal Vascular Diameter	Change from Baseline at 8 weeks	Measurement of Grading of Retinal Vascular Diameter using a fundus camera.
Visual Contrast Sensitivity Function	Change from Baseline at 8 weeks	Perform the Visual Contrast Sensitivity Test (Distance and near) under environmental illumination/dark/bright conditions.

Secondary

Measure	Time frame	Description
The change of Endothelin-1 (ET-1)	Change from Baseline at 8 weeks	Fasting venous blood will be sampled to measure concentrations of ET-1.
The change of Tumor necrosis factor-α (TNF-α)	Change from Baseline at 8 weeks	Fasting venous blood will be sampled to measure concentrations of TNF-α.
Best-corrected visual acuity	Change from Baseline at 8 weeks	Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.
Questionnaire Survey - Ocular Surface Disease Index (OSDI)	Change from Baseline at 8 weeks	The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026