Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

Eye Clinical Trial

Official title:

Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348110
• Other study ID #: CS19152
• Status: Completed
• Phase: N/A
• Start date: April 17, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of blueberry chewable tablets on Eye Health

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult men and women over 20 years old

• Use 3C products over 6 hours per day

• Symptoms of dry eyes or tired eyes

• Tear Break-Up Time is 10 seconds less

• No history of ocular surgery (strabismus surgery, refractive surgery etc.)

Exclusion Criteria:

• Have systemic diseases affecting the front surface of the eyes.

• Long-term use of drugs or eye drops that affect the condition of the front surface of the eyes

• Long-term contact lens wear

Related Conditions & MeSH terms

• Eye

Intervention

Dietary Supplement:
• Placebo tablets
consume 2 tablets per day for 8 weeks
• Blueberry Chewable Tablets
consume 2 tablets 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	Changes of Schirmer's test	Schirmer's test determines whether the eye produces enough tears to keep it moist. Units: mm (in 5minutes)	8 weeks
Primary	Changes of tear meniscus height	Slit lamp Ocular Surface Analyzer is utilized to measure tear meniscus height. Units: mm	8 weeks
Primary	Changes of non-invasive tear break-up time (NITBUT)	Ocular Surface Analyzer is utilized to measure non-invasive tear break-up time. Units: sec	8 weeks
Primary	Tear break-up time (TBUT)	Slit lamp ocular Surface Analyzer is utilized to measure fist tear break-up time with slit lamp. Units: sec	8 weeks
Primary	Changes of accommodation	Speedy-I is utilized to measure the accommodative micro fluctuation test of the ciliary muscle. Units: HFC	8 weeks
Primary	Ocular Surface Disease Index (OSDI)	The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision. Units: point	8 weeks
Secondary	Changes of eye pressure	Eye pressure is measured in millimeters of mercury (mm Hg).	8 weeks
Secondary	Changes of Intraocular pressure (IOP)	Eye pressure is measured in millimeters of mercury (mm Hg). Units: mmHg	8 weeks
Secondary	Changes of Near point of convergence (NPC)	RAF rule were initiated in order to normalize NPC. Record as break/recovery. Units: cm	8 weeks
Secondary	Changes of Stereo vision	The Randot Stereotest is utilized to evaluate the depth perception. Units: sec	8 weeks
Secondary	Changes of binocular motor fusion	The test is utilized to evaluate to assess binocular motor fusion, specifically the extent to which a patient can maintain binocular single vision (BSV) in the presence of increasing vergence demands. Units: prism	8 weeks
Secondary	Changes of Amplitude of accommodation (AA)	The amplitude of accommodation is the maximum potential increase in optical power that an eye can achieve in adjusting its focus. It refers to a certain range of object distances for which the retinal image is as sharply focused as possible. Units: diopter	8 weeks
Secondary	Changes of Amplitude of Flipper facility	Vergence facility (VF) was measured by using a prism flipper to evaluate the ability of the fusional vergence at near with +/-2.00 flipper. Units: cpm	8 weeks
Secondary	Changes of Fundus photography	The fundus is the back of the eye and includes the retina, optic nerve, and retinal blood vessels.	8 weeks