Acupuncture for Dry Eye Syndrome

NCT ID: NCT00969280

Last Updated: 2010-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2009-12-31

Brief 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. Additionally, the investigators will assess the safety of acupuncture treatment.

Conditions

Dry Eye Syndromes

Keywords

Acupuncture; Dry eye syndrome; Ocular Surface Disease Index; Schirmer test; Tear film Break-up time

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standardized Acupuncture group

Group Type: EXPERIMENTAL

Standardized Acupuncture

Intervention Type: DEVICE

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-acupoint shallow penetration group

Group Type: PLACEBO_COMPARATOR

Non-acupuncture point shallow penetration acupuncture

Intervention Type: DEVICE

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.

Interventions

Standardized Acupuncture

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.

Intervention Type: DEVICE

Non-acupuncture point shallow penetration acupuncture

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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

2. Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Department of Medical Research, Korea Institute of Oriental Medicine

Principal Investigators

Sunmi Choi, doctor

Role: STUDY_DIRECTOR

Korea Institute of Oriental Medicine

Taehun Kim, Doctor

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Oriental Medicine

Mi-suk Shin, Master

Role: PRINCIPAL_INVESTIGATOR

Korea Institute of Oriental Medicine

Locations

Clinical Research Center, Korea institute of oriental medicine

Daejeon, Chongchungdo, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 19958541 (View on PubMed)

Other Identifiers

KI0906

Identifier Type: -

Identifier Source: org_study_id