The Effect of DA9301 on Tablet Computer-Induced Asthenopia

• Sponsor: Namyi Gu (Other)
• Overall Status: Completed
• CT.gov ID: NCT02641470
• Collaborator: (none)
• Enrollment: 60
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthenopia	Dietary Supplement: DA9301 (Vaccinium uliginosum extract); Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Trial to Investigate the Effect of DA9301 on Tablet Computer-induced Asthenopia in Humans
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Feb 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. Soft or Hard contact lens use 3 or more days a week

2. History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study

3. Pregnant woman

4. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Namyi Gu

Investigators

• Principal Investigator: Choul Yong Park, MD, PhD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Namyi Gu, Assistant professor, DongGuk University
• ClinicalTrials.gov Identifier: NCT02641470
• Other Study ID Numbers: DA9301_01
• First Posted: Dec 29, 2015
• Last Update Posted: Dec 29, 2015
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Asthenopia

Study Results

No Results Posted as of Dec 29, 2015