Evaluation of Eye Health Benefits of Blueberry Chewable Tablets
1 other identifier
interventional
57
1 country
1
Brief Summary
To assess the efficacy of blueberry chewable tablets on Eye Health
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 15, 2021
May 1, 2020
3 months
April 14, 2020
January 13, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
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 Outcomes (8)
Changes of eye pressure
8 weeks
Changes of Intraocular pressure (IOP)
8 weeks
Changes of Near point of convergence (NPC)
8 weeks
Changes of Stereo vision
8 weeks
Changes of binocular motor fusion
8 weeks
- +3 more secondary outcomes
Study Arms (2)
Placebo tablets
PLACEBO COMPARATORBlueberry Chewable Tablets
EXPERIMENTALInterventions
consume 2 tablets per day for 8 weeks
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TCI Co., Ltd.lead
Study Sites (1)
Chung Shan Medical University
Taichung, 402, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Bo-Yie Chen
Chung Shan Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 15, 2020
Study Start
April 17, 2020
Primary Completion
July 15, 2020
Study Completion
December 31, 2020
Last Updated
January 15, 2021
Record last verified: 2020-05