Evaluation of Eye Health Benefits of Blueberry Chewable Tablets

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04348110
Collaborator
(none)
57
1
2
8.5
6.7

Study Details

Study Description

Brief Summary

To assess the efficacy of blueberry chewable tablets on Eye Health

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo tablets
  • Dietary Supplement: Blueberry Chewable Tablets
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Eye Health Benefits of Blueberry Chewable Tablets
Actual Study Start Date :
Apr 17, 2020
Actual Primary Completion Date :
Jul 15, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. Changes of tear meniscus height [8 weeks]

      Slit lamp Ocular Surface Analyzer is utilized to measure tear meniscus height. Units: mm

    3. 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

    4. 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

    5. Changes of accommodation [8 weeks]

      Speedy-I is utilized to measure the accommodative micro fluctuation test of the ciliary muscle. Units: HFC

    6. 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

    1. Changes of eye pressure [8 weeks]

      Eye pressure is measured in millimeters of mercury (mm Hg).

    2. Changes of Intraocular pressure (IOP) [8 weeks]

      Eye pressure is measured in millimeters of mercury (mm Hg). Units: mmHg

    3. Changes of Near point of convergence (NPC) [8 weeks]

      RAF rule were initiated in order to normalize NPC. Record as break/recovery. Units: cm

    4. Changes of Stereo vision [8 weeks]

      The Randot Stereotest is utilized to evaluate the depth perception. Units: sec

    5. 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

    6. 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

    7. 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

    8. Changes of Fundus photography [8 weeks]

      The fundus is the back of the eye and includes the retina, optic nerve, and retinal blood vessels.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chung Shan Medical University Taichung Taiwan 402

    Sponsors and Collaborators

    • TCI Co., Ltd.

    Investigators

    • Principal Investigator: Bo-Yie Chen, Chung Shan Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TCI Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04348110
    Other Study ID Numbers:
    • CS19152
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 15, 2021