Acupuncture for Dry Eye Syndrome

Korea Institute of Oriental Medicine

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Device: Non-acupuncture point shallow penetration acupuncture; Device: Standardized Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT00969280

KI0906

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Standardized Acupuncture group

Experimental group

Treatment:

Device: Standardized Acupuncture

Non-acupoint shallow penetration group

Placebo Comparator group

Treatment:

Device: Non-acupuncture point shallow penetration acupuncture