Evaluation of Eye Health Benefits of Black Tomato Extract

High Myopia Clinical Trial

Official title:

Evaluation of Eye Health Benefits of Black Tomato Extract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412393
• Other study ID #: CS1-23170
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: February 7, 2025

Study information

• Verified date: May 2024
• Source: TCI Co., Ltd.
• Contact: Bo-Yie Chen
• Phone: +886-04-24730022
• Email: boychen[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 7, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye
• High Myopia
• Myopia

Intervention

Dietary Supplement:
• Black tomato extract powder
take 2 packets per day for 8 weeks
• Placebo powder
take 2 packets per day for 8 weeks

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure Measurement (IOP)	Measurement of Intraocular Pressure using a non-contact tonometer. Unit: mmHg	Change from Baseline at 8 weeks
Primary	Grading of Retinal Vascular Diameter	Measurement of Grading of Retinal Vascular Diameter using a fundus camera.	Change from Baseline at 8 weeks
Primary	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
Primary	Negative Fusional Vergence (NFV)	Measurement of Negative Fusional Vergence using a phoropter.	Change from Baseline at 8 weeks
Primary	Positive Fusional Vergence (PFV)	Measurement of Positive Fusional Vergence using a phoropter.	Change from Baseline at 8 weeks
Primary	Negative Relative Accommodation (NRA)	Measurement of Negative Relative Accommodation using a phoropter.	Change from Baseline at 8 weeks
Primary	Positive Relative Accommodation (PRA)	Measurement of Positive Relative Accommodation using a phoropter.	Change from Baseline at 8 weeks
Primary	Accommodative Facility	Measurement of Accommodative Facility using a Flipper lens ±2.00D.	Change from Baseline at 8 weeks
Secondary	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
Secondary	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
Secondary	The change of Tumor necrosis factor-a (TNF-a)	Fasting venous blood will be sampled to measure concentrations of TNF-a.	Change from Baseline at 8 weeks
Secondary	Best-corrected visual acuity	Measurement of Best-corrected visual acuity (distance and near) using a logMAR chart.	Change from Baseline at 8 weeks