Evaluation of Eye Health Benefits of Black Tomato Extract

NCT06412393 | Completed

• 1 other identifier: CS1-23170
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eye; High Myopia

Outcome Measures

Primary Outcomes (8)

• Intraocular Pressure Measurement (IOP)

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

  Change from Baseline at 8 weeks

• Grading of Retinal Vascular Diameter

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

  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.

  Change from Baseline at 8 weeks

• Negative Fusional Vergence (NFV)

  Measurement of Negative Fusional Vergence using a phoropter.

  Change from Baseline at 8 weeks

• Positive Fusional Vergence (PFV)

  Measurement of Positive Fusional Vergence using a phoropter.

  Change from Baseline at 8 weeks

• Negative Relative Accommodation (NRA)

  Measurement of Negative Relative Accommodation using a phoropter.

  Change from Baseline at 8 weeks

• Positive Relative Accommodation (PRA)

  Measurement of Positive Relative Accommodation using a phoropter.

  Change from Baseline at 8 weeks

• Accommodative Facility

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

  Change from Baseline at 8 weeks

Secondary Outcomes (4)

• Questionnaire Survey - Ocular Surface Disease Index (OSDI)

  Change from Baseline at 8 weeks

• The change of Endothelin-1 (ET-1)

  Change from Baseline at 8 weeks

• The change of Tumor necrosis factor-α (TNF-α)

  Change from Baseline at 8 weeks

• Best-corrected visual acuity

  Change from Baseline at 8 weeks

Study Arms (2)

Placebo powder

PLACEBO COMPARATOR

Dietary Supplement: Placebo powder

Dietary Supplement: Placebo powder

Black tomato extract powder

EXPERIMENTAL

Dietary Supplement: Black tomato extract powder

Dietary Supplement: Black tomato extract powder

Interventions

Black tomato extract powder DIETARY_SUPPLEMENT

take 2 packets per day for 8 weeks

Black tomato extract powder

Placebo powder DIETARY_SUPPLEMENT

take 2 packets per day for 8 weeks

Placebo powder

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

Location

Study Officials

• Bo-Yie Chen boychen@csmu.edu.tw

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 14, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

TW (1)