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The Effect of DA9301 on Tablet Computer-Induced Asthenopia

NCT ID: NCT02641470

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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

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Conditions

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Asthenopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DA9301

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

Group Type EXPERIMENTAL

DA9301 (Vaccinium uliginosum extract)

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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DA9301 (Vaccinium uliginosum extract)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Namyi Gu

OTHER

Sponsor Role lead

Responsible Party

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Namyi Gu

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Choul Yong Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

References

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Park CY, Gu N, Lim CY, Oh JH, Chang M, Kim M, Rhee MY. The effect of Vaccinium uliginosum extract on tablet computer-induced asthenopia: randomized placebo-controlled study. BMC Complement Altern Med. 2016 Aug 18;16:296. doi: 10.1186/s12906-016-1283-x.

Reference Type DERIVED
PMID: 27538497 (View on PubMed)

Other Identifiers

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DA9301_01

Identifier Type: -

Identifier Source: org_study_id