AsthenopiaNCT02641470
The Effect of DA9301 on Tablet Computer-Induced Asthenopia
A study testing DA9301 (Vaccinium uliginosum extract) in people with Asthenopia, run by Namyi Gu.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthenopia
- What is being tested?
- DA9301 (Vaccinium uliginosum extract)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
- Malignant disease
- Active hepatitis (type B and C)
- Acute or chronic infectious disease
- Renal disease
About this study
Official title: 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.
- Conditions
- Asthenopia
- Being tested
- DA9301 (Vaccinium uliginosum extract), Placebo
- Medical subject headings
- Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA9301 (Vaccinium uliginosum extract)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| DA9301 | Experimental | Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks. Receives: Dietary Supplement: DA9301 (Vaccinium uliginosum extract) |
| Placebo | Placebo comparator | Orally administration of placebo pills (1000 mg/day) for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the modified questionnaire scores proposed by Ames et al.
Measured: before and immediately after tablet computer use on Day 0 and Day 29 (deviation window: Day 21-31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthenopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namyi Gu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Namyi Gu, DongGuk University
- Investigators
- Choul Yong Park, MD, PhD, Principal investigator, oph0112@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641470
- Sponsor's protocol ID
- DA9301_01
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27538497
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Effect of DA9301 on Tablet Computer-induced Asthenopia in Humans
- ClinicalTrials.gov ID
- NCT02641470
- Acronym / sponsor ID
- DA9301_01
- Conditions
- Asthenopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Namyi GuUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA9301 | Experimental | Dietary Supplement: DA9301 (Vaccinium uliginosum extract)Orally administration of DA9301 (Vaccinium uliginosum extract) pills (1000 mg/day) for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOrally administration of placebo pills (1000 mg/day) for 4 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (19 listed)
- Ocular disease in either eye
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA9301 (Vaccinium uliginosum extract) | Dietary supplement | DA9301 |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Derived from this study: PubMed 27538497Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choul Yong Park, MD, PhD principal investigator
oph0112@gmail.com
Questions about this trial
What is this clinical trial studying?
A study testing DA9301 (Vaccinium uliginosum extract) in people with Asthenopia, run by Namyi Gu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.