Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

Study Overview
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Brief Summary
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To assess the efficacy of blueberry chewable tablets on Eye Health

Official Title
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Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

Conditions
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Eye

Intervention / Treatment
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* Dietary Supplement: Placebo tablets
* Dietary Supplement: Blueberry Chewable Tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo tablets<br> | Dietary Supplement: Placebo tablets<br>* consume 2 tablets per day for 8 weeks<br>|
| Experimental: Blueberry Chewable Tablets<br> | Dietary Supplement: Blueberry Chewable Tablets<br>* consume 2 tablets per day for 8 weeks<br>* Other names: NutraView® Tablets;|

What is the study measuring?
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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 |