To Study the Effects of Baby Drink on Vision Care

NCT05778201 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: CRREC-111-088
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Baby Drink is a formula based on lutein, mixed with blueberry fermented liquid, vitamins and minerals. Lutein is an effective antioxidant to prevent retinal damage caused by blue light, but it cannot be produced in the human body and depends on dietary intake. Blueberry fermented liquid is rich in polyphenolic compounds with excellent antioxidant capacity and the potential to reduce oxidative damage to eye cells caused by ultraviolet rays. With the prevalence of 3C products, myopia patients are increasing year by year in various regions, and suffer from eye diseases or vision loss with different degrees of complications. In this study, the subjects were provided with Baby Drink and tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. The aim of this study is to investigate the protection of Baby Drink on visual acuity and visual fatigue.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Eye fatigue questionnaire

  1. Eye fatigue were evaluated according to The Ocular Surface Disease Index (OSDI) introduced in 1997 by the Outcomes Research Group (Allergan Inc., Irvine, CA). 2. Content including: (1) Eye swelling, (2) Eye soreness, (3) Photophobia, (4) Blurred vision, (5) Dry eye, (6) Foreign body sensation, (7) Tearing, (8) General discomfort related to eye fatigue. 3. Scores are expressed on a scale of 0-3. 0 = No symptoms , 1 = Occasionally (≤1 time/day), 2 = Sometimes (1-3 times/day), 3 = Frequently (\>3 times/day), a low score means less visual fatigue and better eye quality.

  1 month

• Best vision test

  1. Visual acuity was tested with the Snellen Eye Test Chart and recorded with the score proposed by Snellen. 2. Subjects were asked to stand 20 feet away to observe the snellen E-chart and record the smallest visual mark. 3. Recording method: 20/20 (1.0) is defined as normal vision, lower than this score indicates that the subject has ametropia, and higher than this indicates that the subject's vision is higher than the general standard

  1 month

Study Arms (1)

Baby Drink group

EXPERIMENTAL

1 package/ day for 1 month

Biological: Baby Drink group

Interventions

Baby Drink group BIOLOGICAL

1 packge (20 ml)/ day for 1 month

Baby Drink group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 or over
• Willing to participate in this study and sign the subject's consent form
• Myopia less than 700 degrees

You may not qualify if:

• Have consumed related eye care products in past 3 months
• Those who have eye infection in the past 3 months
• People who have been diagnosed with any eye diseases in past 3 months
• Those who are allergic to cicadae

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Asia university

Taichung, 413, Taiwan

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Hui Wen Lin, ph.D

  Asia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wen Lin, ph.D

CONTACT

04-23323456; d9138001@gmail.com

Tzu Chun Chen, Master

CONTACT

0915451008; cherish4488@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Baby Drink Intervention group

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: March 8, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TW (1)