Acupuncture for Dry Eye Syndrome

Dry Eye Syndromes Clinical Trial

Official title:

Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969280
• Other study ID #: KI0906
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2009
• Last updated: December 17, 2010
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: Korea Institute of Oriental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Research Center, Korea institute of oriental medicine	Daejeon	Chongchungdo

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Oriental Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visit 11 (after 3 weeks from baseline)	No
Secondary	Visual Analogue Scale of Self Symptoms		every visit	No
Secondary	Schirmer 1 Test		visit 1,10	No
Secondary	Tear Film Break-up Time : BUT		Visit 1, 10	No
Secondary	Medication Quantification Scale (MQS)		every visit	No
Secondary	General Assessment		visit 11	No