The Effect of DA9301 on Tablet Computer-Induced Asthenopia

NCT02641470 | Completed

• 1 other identifier: DA9301_01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthenopia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

DA9301

EXPERIMENTAL

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

Dietary Supplement: DA9301 (Vaccinium uliginosum extract)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

DA9301 (Vaccinium uliginosum extract) DIETARY_SUPPLEMENT

DA9301

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Namyi Gu: lead

Related Publications (1)

• 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.

  PMID: 27538497 DERIVED

MeSH Terms

Conditions

Asthenopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Choul Yong Park, MD, PhD

  oph0112@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Last Updated: December 29, 2015

Record last verified: 2015-12