Evaluation of Eye Health Benefits of Black Tomato Extract

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

Study Overview

• Status: Recruiting
• Conditions: High Myopia; Eye
• Intervention / Treatment: Dietary supplement: Placebo powder; Dietary supplement: Black tomato extract powder

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo-Yie Chen; Phone Number: 11708 +886-04-24730022; Email: boychen@csmu.edu.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 402
    • Recruiting
    • Chung Shan Medical University
    • Contact: Bo-Yie Chen; Phone Number: 11708 +886-04-24730022; Email: boychen@csmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo powder; Dietary Supplement: Placebo powder	Dietary supplement: Placebo powder; take 2 packets per day for 8 weeks
Experimental: Black tomato extract powder; Dietary Supplement: Black tomato extract powder	Dietary supplement: Black tomato extract powder; take 2 packets per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire Survey - Ocular Surface Disease Index (OSDI)	The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.	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.	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.	Change from Baseline at 8 weeks
Best-corrected visual acuity	Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.	Change from Baseline at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Bo-Yie Chen boychen@csmu.edu.tw, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 7, 2025

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CS1-23170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No