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NCT Number: NCT02641470

The Effect of DA9301 on Tablet Computer-Induced Asthenopia

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.

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Key information

Conditions

Asthenopia Eye Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

DA9301 (Vaccinium uliginosum extract)

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Namyi Gu

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Dec 29, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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