The Effect of DA9301 on Tablet Computer-Induced Asthenopia

Asthenopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641470
• Other study ID #: DA9301_01
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: December 28, 2015
• Start date: January 2014

Study information

• Verified date: December 2015
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthenopia

Intervention

Dietary Supplement:
• DA9301 (Vaccinium uliginosum extract)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Namyi Gu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No