The Effect of DA9301 on Tablet Computer-Induced Asthenopia

Namyi Gu

Status: Completed

Conditions: Asthenopia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: DA9301 (Vaccinium uliginosum extract)

Study type: Interventional

Funder types: Other

Identifiers

NCT02641470

DA9301_01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

DA9301

Experimental group

Description:

Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks.

Treatment:

Dietary Supplement: DA9301 (Vaccinium uliginosum extract)

Placebo

Placebo Comparator group

Description:

Orally administration of placebo pills (1000 mg/day) for 4 weeks.

Treatment:

Dietary Supplement: Placebo