Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

Not Applicable

Completed

• Conditions: Eye
• Interventions: Dietary Supplement: Placebo tablets; Dietary Supplement: Blueberry Chewable Tablets

• Registration Number: NCT04348110
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess the efficacy of blueberry chewable tablets on Eye Health

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-15
• Study Start: 2020-04-17
• Status Verified: 2020-05
• Primary Completion: 2020-07-15
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo tablets	Placebo tablets	-
Blueberry Chewable Tablets	Blueberry Chewable Tablets	-

Primary Outcome Measures

Name	Time	Method
Changes of accommodation	8 weeks	Speedy-I is utilized to measure the accommodative micro fluctuation test of the ciliary muscle. Units: HFC
Changes of Schirmer's test	8 weeks	Schirmer's test determines whether the eye produces enough tears to keep it moist. Units: mm (in 5minutes)
Changes of non-invasive tear break-up time (NITBUT)	8 weeks	Ocular Surface Analyzer is utilized to measure non-invasive tear break-up time. Units: sec
Changes of tear meniscus height	8 weeks	Slit lamp Ocular Surface Analyzer is utilized to measure tear meniscus height. Units: mm
Tear break-up time (TBUT)	8 weeks	Slit lamp ocular Surface Analyzer is utilized to measure fist tear break-up time with slit lamp. Units: sec
Ocular Surface Disease Index (OSDI)	8 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan