Dry Eye Syndromes Clinical Trial
Official title:
Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Clinical Research Center, Korea institute of oriental medicine | Daejeon | Chongchungdo |
Lead Sponsor | Collaborator |
---|---|
Korea Institute of Oriental Medicine |
Korea, Republic of,
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 |
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