Back to resultsThe Effect of DA9301 on Tablet Computer-Induced Asthenopia
Primary Purpose
Asthenopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DA9301 (Vaccinium uliginosum extract)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthenopia
Eligibility Criteria
Inclusion Criteria:
1. Healthy subject aged 20 to 65 years with more than 2 hours of daily use of a smart phone or computer including a tablet and television
Exclusion Criteria:
Ocular disease in either eye
- Ocular surface disease
- Best corrected visual acuity < 20/30
- Intraocular pressure > 21 mmHg
- Optical coherence tomography proven retinal nerve fiber defect
- Significant cataract (lens opacities classification system III)
- Significant entropion or ectropion
- Significant tear drainage problem proved with fluorescein dye dilution test
- Soft or Hard contact lens use 3 or more days a week
- History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study
- Pregnant woman
Systemic disease
- Uncontrolled hypertension (systolic /diastolic blood pressure > 140/90mmHg)
- Uncontrolled diabetes mellitus (fasting blood glucose level > 180mg/dL)
- Rheumatoid arthritis
- Malignant disease
- Active hepatitis (type B and C)
- Acute or chronic infectious disease
- Renal disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DA9301
Placebo
Arm Description
Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks.
Orally administration of placebo pills (1000 mg/day) for 4 weeks.
Outcomes
Primary Outcome Measures
Change of the modified questionnaire scores proposed by Ames et al.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02641470
Brief Title
The Effect of DA9301 on Tablet Computer-Induced Asthenopia
Official Title
Clinical Trial to Investigate the Effect of DA9301 on Tablet Computer-induced Asthenopia in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Namyi Gu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant is native to cool temperature regions of the Northern Hemisphere. Considering its antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a significant role in treating various ocular pathologies. The investigators performed a randomized, case-controlled study in healthy subjects and investigated the protective effect of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA9301
Arm Type
Experimental
Arm Description
Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Orally administration of placebo pills (1000 mg/day) for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
DA9301 (Vaccinium uliginosum extract)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change of the modified questionnaire scores proposed by Ames et al.
Time Frame
before and immediately after tablet computer use on Day 0 and Day 29 (deviation window: Day 21-31)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Healthy subject aged 20 to 65 years with more than 2 hours of daily use of a smart phone or computer including a tablet and television
Exclusion Criteria:
Ocular disease in either eye
Ocular surface disease
Best corrected visual acuity < 20/30
Intraocular pressure > 21 mmHg
Optical coherence tomography proven retinal nerve fiber defect
Significant cataract (lens opacities classification system III)
Significant entropion or ectropion
Significant tear drainage problem proved with fluorescein dye dilution test
Soft or Hard contact lens use 3 or more days a week
History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study
Pregnant woman
Systemic disease
Uncontrolled hypertension (systolic /diastolic blood pressure > 140/90mmHg)
Uncontrolled diabetes mellitus (fasting blood glucose level > 180mg/dL)
Rheumatoid arthritis
Malignant disease
Active hepatitis (type B and C)
Acute or chronic infectious disease
Renal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choul Yong Park, MD, PhD
Organizational Affiliation
oph0112@gmail.com
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27538497
Citation
Park CY, Gu N, Lim CY, Oh JH, Chang M, Kim M, Rhee MY. The effect of Vaccinium uliginosum extract on tablet computer-induced asthenopia: randomized placebo-controlled study. BMC Complement Altern Med. 2016 Aug 18;16:296. doi: 10.1186/s12906-016-1283-x.
Results Reference
derived
Learn more about this trial
The Effect of DA9301 on Tablet Computer-Induced Asthenopia
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