The Effect of DA9301 on Tablet Computer-Induced Asthenopia

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial to Investigate the Effect of DA9301 on Tablet Computer-induced Asthenopia in Humans

Conditions
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Asthenopia

Intervention / Treatment
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* Dietary Supplement: DA9301 (Vaccinium uliginosum extract)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA9301<br>Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks. | Dietary Supplement: DA9301 (Vaccinium uliginosum extract)<br> <br> |
| Placebo Comparator: Placebo<br>Orally administration of placebo pills (1000 mg/day) for 4 weeks. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the modified questionnaire scores proposed by Ames et al. |  | before and immediately after tablet computer use on Day 0 and Day 29 (deviation window: Day 21-31) |