Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

To assess the efficacy of blueberry chewable tablets on Eye Health

Study Overview

• Status: Completed
• Conditions: Eye
• Intervention / Treatment: Dietary supplement: Placebo tablets; Dietary supplement: Blueberry Chewable Tablets

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 402
    • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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 tablets	Dietary supplement: Placebo tablets; consume 2 tablets per day for 8 weeks
Experimental: Blueberry Chewable Tablets	Dietary supplement: Blueberry Chewable Tablets; consume 2 tablets per day for 8 weeks; Other Names: NutraView® Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes of tear meniscus height	Slit lamp Ocular Surface Analyzer is utilized to measure tear meniscus height. Units: mm	8 weeks
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
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
Changes of accommodation	Speedy-I is utilized to measure the accommodative micro fluctuation test of the ciliary muscle. Units: HFC	8 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of eye pressure	Eye pressure is measured in millimeters of mercury (mm Hg).	8 weeks
Changes of Intraocular pressure (IOP)	Eye pressure is measured in millimeters of mercury (mm Hg). Units: mmHg	8 weeks
Changes of Near point of convergence (NPC)	RAF rule were initiated in order to normalize NPC. Record as break/recovery. Units: cm	8 weeks
Changes of Stereo vision	The Randot Stereotest is utilized to evaluate the depth perception. Units: sec	8 weeks
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
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
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
Changes of Fundus photography	The fundus is the back of the eye and includes the retina, optic nerve, and retinal blood vessels.	8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Bo-Yie Chen, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CS19152

Drug and device information, study documents

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