The Effect of DA9301 on Tablet Computer-Induced Asthenopia

December 28, 2015 updated by: Namyi Gu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
before and immediately after tablet computer use on Day 0 and Day 29 (deviation window: Day 21-31)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namyi Gu

Investigators

  • Principal Investigator: Choul Yong Park, MD, PhD, oph0112@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

December 28, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA9301_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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