Acupuncture for Dry Eye

NCT01105221 | Completed Phase 3 DMC

• 1 other identifier: KI1001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess whether acupuncture is more effective than artificial tear drop in the treatment of dry eye.

Conditions

Dry Eye

Keywords

Acupuncture; Dry eye; Artificial tear drop; Mixed method approach; Qualitative study; Cost effectiveness analysis; Tear cytokine analysis

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  This questionnaire is a 12-item instrument for ocular irritation and impact on visual function in dry eye sufferers. It can provide quantifiable results of dry eye symptom frequency and vision-related functioning. Korean version of the OSDI questionnaire will be used. Follow up measurement will be assessed after 4, 5, 9 and 13 weeks from the first visit.

  Up to 13 weeks

Secondary Outcomes (9)

• Visual analogue scale (VAS) for self-assessment of ocular discomfort

  Up to 13 weeks

• Schirmer I test with anaesthesia

  Up to 13 weeks

• Tear Film Break Up Time (BUT)

  Up to 13 weeks

• General Assessment by acupuncture practitioner and participants

  Up to 5 weeks

• Self reports about experiences of using other dry eye-related treatments after the end of each intervention.

  Up to 13 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

Device: Acupuncture

Artificial tear drop

ACTIVE COMPARATOR

Drug: Refresh Plus

Interventions

Acupuncture DEVICE

Participants, allocated to this group, will have twelve times of acupuncture treatment in four weeks. Seventeen acupuncture points, which are both BL2, GB14, TE23, Ex1, ST1, GB20, LI4, LI11 and single GV23, will be selected and disposable 0.20\*30mm acupuncture needles(Dongbang Co., Korea) will be inserted on these points. Strong 'deqi' sensation will be induced by twisting acupuncture needles and retained for 20 minutes before removed.

Acupuncture

Refresh Plus DRUG

Participants, allocated to this group, will be offered preservative-free and single-use Refresh plus (Sodium carboxymethylcellulose). They should use artificial tear in both eyes at least once a day for four weeks.

Also known as: Brand name: ALLERGAN

Artificial tear drop

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have had dry eye syndromes in single eye or in both eyes (ICD-10 : H04.1). He or she must have both of the conditions below:
• Patients who have dry eye symptoms such as itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
• Patients whose tear film break-up time is below 10 seconds and Schirmer I test results is below 10mm/5sec.

You may not qualify if:

• Patients who have defects of the eyelid or eyelashes
• Acute infection of the eyelid, eyeball or eye accessories
• Stevens-Johnson syndrome
• Vitamin A deficiency
• Eye or accessory defects due to external injuries
• A past history of surgical operation related to the eye in last three months
• Punctual occlusion
• Current usage of contact lenses
• Sequelae of facial palsy,
• Current usage of anti-inflammatory eye drops in the last two weeks
• Pregnancy
• Using history of traditional medicinal treatment such as acupuncture, moxibustion and herbal medicine in the last one month

Sponsors & Collaborators

• Korea Institute of Oriental Medicine: lead
• DongGuk University: collaborator
• DONGSHIN University Oriental Hospital: collaborator

Study Sites (3)

Clinical Research Center of DongGuk Univ. Internaltional Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

Clinical Research Center of Korea Institute of Oriental Medicine

Daejeon, 301-724, South Korea

Location

Clinical Research Center of DongShin Univ. Oriental Hospital

Gwangju, 503-232, South Korea

Location

Related Publications (2)

• Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Choi JB, Hong KE, Lee SD, Choi SM. Acupuncture for the treatment of dry eye: a multicenter randomised controlled trial with active comparison intervention (artificial teardrops). PLoS One. 2012;7(5):e36638. doi: 10.1371/journal.pone.0036638. Epub 2012 May 17.

  PMID: 22615787 DERIVED

• Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Lee SD, Choi JB, Choi SM. Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol. Trials. 2010 Nov 16;11:107. doi: 10.1186/1745-6215-11-107.

  PMID: 21078194 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sun-Mi Choi, Dr

  Korea Institute of Oriental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 10, 2011

Record last verified: 2010-04

Locations

KR (3)