Clinical trial NCT00969280: Acupuncture for Dry Eye Syndrome
Official title: Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Keywords: Acupuncture
Dry eye syndrome
Ocular Surface Disease Index
Schirmer test
Tear film Break-up time
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
First posted: 2009-09-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ocular Surface Disease Index : OSDI
timeFrame: Visit 11 (after 3 weeks from baseline)
Secondary outcomes:
measure: Visual Analogue Scale of Self Symptoms
timeFrame: every visit
measure: Schirmer 1 Test
timeFrame: visit 1,10
measure: Tear Film Break-up Time : BUT
timeFrame: Visit 1, 10
measure: Medication Quantification Scale (MQS)
timeFrame: every visit
measure: General Assessment
timeFrame: visit 11
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Clinical Research Center, Korea institute of oriental medicine
state: Chongchungdo
Study officials:
affiliation: Korea Institute of Oriental Medicine
name: Sunmi Choi, doctor
role: STUDY_DIRECTOR
affiliation: Korea Institute of Oriental Medicine
name: Taehun Kim, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Institute of Oriental Medicine
name: Mi-suk Shin, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.