The Effect of DA9301 on Tablet Computer-Induced Asthenopia

Not Applicable

Completed

• Conditions: Asthenopia
• Interventions: Dietary Supplement: DA9301 (Vaccinium uliginosum extract); Dietary Supplement: Placebo

• Registration Number: NCT02641470
• Lead Sponsor: Namyi Gu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-02
• Status Verified: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-28
• Last Update Submitted: 2015-12-28
• Study First Posted: 2015-12-29
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

1. 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

2. Soft or Hard contact lens use 3 or more days a week

3. History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study

4. Pregnant woman

5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA9301	DA9301 (Vaccinium uliginosum extract)	Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks.
Placebo	Placebo	Orally administration of placebo pills (1000 mg/day) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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)