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OpenTrials
Completed

NCT Number: NCT06412393

Evaluation of Eye Health Benefits of Black Tomato Extract

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

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Key information

Conditions

Eye High Myopia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 402, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Black tomato extract powder

Dietary Supplement

take 2 packets per day for 8 weeks

Placebo Powder

Dietary Supplement

take 2 packets per day for 8 weeks

Primary outcomes

  1. Intraocular Pressure Measurement (IOP)

    Time frame: Change from Baseline at 8 weeks

    Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg

  2. Grading of Retinal Vascular Diameter

    Time frame: Change from Baseline at 8 weeks

    Measurement of Grading of Retinal Vascular Diameter using a fundus camera.

  3. 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.

  4. Negative Fusional Vergence (NFV)

    Time frame: Change from Baseline at 8 weeks

    Measurement of Negative Fusional Vergence using a phoropter.

  5. Positive Fusional Vergence (PFV)

    Time frame: Change from Baseline at 8 weeks

    Measurement of Positive Fusional Vergence using a phoropter.

  6. Negative Relative Accommodation (NRA)

    Time frame: Change from Baseline at 8 weeks

    Measurement of Negative Relative Accommodation using a phoropter.

  7. Positive Relative Accommodation (PRA)

    Time frame: Change from Baseline at 8 weeks

    Measurement of Positive Relative Accommodation using a phoropter.

  8. Accommodative Facility

    Time frame: Change from Baseline at 8 weeks

    Measurement of Accommodative Facility using a Flipper lens ±2.00D.

Secondary outcomes

  1. Questionnaire Survey - Ocular Surface Disease Index (OSDI)

    Time frame: Change from Baseline at 8 weeks

    The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.

  2. The change of Endothelin-1 (ET-1)

    Time frame: Change from Baseline at 8 weeks

    Fasting venous blood will be sampled to measure concentrations of ET-1.

  3. The change of Tumor necrosis factor-α (TNF-α)

    Time frame: Change from Baseline at 8 weeks

    Fasting venous blood will be sampled to measure concentrations of TNF-α.

  4. Best-corrected visual acuity

    Time frame: Change from Baseline at 8 weeks

    Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 14, 2024
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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