Dry Eye SyndromesPhase 3NCT00969280
Acupuncture for Dry Eye Syndrome
A Phase 3 study testing Standardized Acupuncture and Non-acupuncture point shallow penetration acupuncture in people with Dry Eye Syndromes, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
Trial summary
This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Standardized Acupuncture and Non-acupuncture point shallow penetration acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:
- Patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
- Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test
Who cannot join
- Those who have defects of eyelid or eyelashes
- Those who have acute infection of eyelid, eyeball or accessories of eye
- Those who have Stevens-Johnson syndromes or Pemphigoids
- Those who have Vitamin A deficiency
- Those who have any defects of eye or accessories of eye by external injuries
- Those who have undergone any surgical operation for eye during last 3 months
Show all 13Show fewer
- Those who are using contact lens
- Those who have any difficulties about eye opening or eye closing due to facial palsy
- Those who have undergone punctual occlusion surgery
- Those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops)
- Those who have systemic immune therapy
- Those who are pregnant or have any plan for pregnancy
- Those who are not appropriate to this study by investigators decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Research Center, Korea institute of oriental medicine
Daejeon, Chongchungdo, 302-869
About this study
Official title: Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study
This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.
- Conditions
- Dry Eye Syndromes
- Being tested
- Standardized Acupuncture, Non-acupuncture point shallow penetration acupuncture
- Keywords
- Acupuncture, Dry eye syndrome, Ocular Surface Disease Index, Schirmer test, Tear film Break-up time
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized AcupunctureDevice
Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks.
According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle.
All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes.
Non-acupuncture point shallow penetration acupunctureDevice
Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks.
Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Acupuncture group | Experimental | Not described Receives: Device: Standardized Acupuncture |
| Non-acupoint shallow penetration group | Placebo comparator | Not described Receives: Device: Non-acupuncture point shallow penetration acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index : OSDI
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.
Measured: Visit 11 (after 3 weeks from baseline)
Secondary outcomes (5)
Visual Analogue Scale of Self Symptoms
Measured: every visit
Schirmer 1 Test
Measured: visit 1,10
Tear Film Break-up Time : BUT
Measured: Visit 1, 10
Medication Quantification Scale (MQS)
Measured: every visit
General Assessment
Measured: visit 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Institute of Oriental Medicine
- Sponsor type
- Other government
- Investigators
- Sunmi Choi, doctor, Study director, Korea Institute of Oriental MedicineTaehun Kim, Doctor, Principal investigator, Korea Institute of Oriental MedicineMi-suk Shin, Master, Principal investigator, Korea Institute of Oriental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969280
- Sponsor's protocol ID
- KI0906
- Status last verified
- Sep 2010
- First submitted
- 31 Aug 2009
- Last updated
- 21 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kim TH, Kim JI, Shin MS, Lee MS, Choi JY, Jung SY, Kim AR, Seol JU, Choi SM. Acupuncture for dry eye: a randomised controlled trial protocol. Trials. 2009 Dec 3;10:112. doi: 10.1186/1745-6215-10-112.
PubMed 19958541
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study
- ClinicalTrials.gov ID
- NCT00969280
- Acronym / sponsor ID
- KI0906
- Conditions
- Dry Eye Syndromes
- Keywords
- Acupuncture, Dry eye syndrome, Ocular Surface Disease Index, Schirmer test, Tear film Break-up time
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Korea Institute of Oriental MedicineOther government
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Posted 20 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Acupuncture group | Experimental | Device: Standardized Acupuncture |
| Non-acupoint shallow penetration group | Placebo comparator | Device: Non-acupuncture point shallow penetration acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:
Key exclusion criteria (13 listed)
- Those who have defects of eyelid or eyelashes
- Those who have acute infection of eyelid, eyeball or accessories of eye
- Those who have Stevens-Johnson syndromes or Pemphigoids
- Those who have Vitamin A deficiency
- Those who have any defects of eye or accessories of eye by external injuries
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 |
|---|---|---|
| Standardized AcupunctureAcupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks. According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle. All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes. | Device | Standardized Acupuncture group |
| Non-acupuncture point shallow penetration acupunctureAcupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks. Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes. | Device | Non-acupoint shallow penetration group |
Primary outcome
Ocular Surface Disease Index : OSDI
Time frame: Visit 11 (after 3 weeks from baseline)
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.
5 secondary outcomes
Visual Analogue Scale of Self Symptoms
Time frame: every visit
Schirmer 1 Test
Time frame: visit 1,10
Tear Film Break-up Time : BUT
Time frame: Visit 1, 10
Medication Quantification Scale (MQS)
Time frame: every visit
General Assessment
Time frame: visit 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19958541Kim TH, Kim JI, Shin MS, Lee MS, Choi JY, Jung SY, Kim AR, Seol JU, Choi SM. Acupuncture for dry eye: a randomised controlled trial protocol. Trials. 2009 Dec 3;10:112. doi: 10.1186/1745-6215-10-112.
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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.
Sunmi Choi, doctor study director
Korea Institute of Oriental Medicine
Taehun Kim, Doctor principal investigator
Korea Institute of Oriental Medicine
Mi-suk Shin, Master principal investigator
Korea Institute of Oriental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standardized Acupuncture and Non-acupuncture point shallow penetration acupuncture in people with Dry Eye Syndromes, run by Korea Institute of Oriental Medicine at 1 site in South Korea.
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 3 inclusion and 13 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 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ocular Surface Disease Index : OSDI (time frame: Visit 11 (after 3 weeks from baseline)). 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 NCT00969280, 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 21 Dec 2010.