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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01105221 |
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Date of registration:
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13/04/2010 |
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Primary sponsor: |
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Public title:
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Acupuncture for Dry Eye
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Scientific title:
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Acupuncture for Dry Eye: a Multicenter Randomized Controlled Trial With Active Comparison Intervention (Artificial Tear Drop) Using a Mixed Method Approach |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01105221 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sun-Mi Choi, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korea Institute of Oriental Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have had dry eye syndromes in single eye or in both eyes (ICD-10 :
H04.1). He or she must have both of the conditions below:
1. Patients who have dry eye symptoms such as itching, ocular foreign body
sensation, ocular burning, ocular pain, ocular dryness, blurred vision,
sensation of photophobia, ocular redness, sensation of tearing
2. Patients whose tear film break-up time is below 10 seconds and Schirmer I test
results is below 10mm/5sec.
Exclusion Criteria:
- Patients who have defects of the eyelid or eyelashes
- Acute infection of the eyelid, eyeball or eye accessories
- Stevens-Johnson syndrome
- Vitamin A deficiency
- Eye or accessory defects due to external injuries
- A past history of surgical operation related to the eye in last three months
- Punctual occlusion
- Current usage of contact lenses
- Sequelae of facial palsy,
- Current usage of anti-inflammatory eye drops in the last two weeks
- Pregnancy
- Using history of traditional medicinal treatment such as acupuncture, moxibustion and
herbal medicine in the last one month
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dry Eye
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Intervention(s)
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Device: Acupuncture
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Drug: Refresh Plus
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Primary Outcome(s)
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Ocular Surface Disease Index (OSDI)
[Time Frame: Up to 13 weeks]
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Secondary Outcome(s)
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Case reports on adverse events for the evaluation of safety
[Time Frame: Up to 13 weeks]
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Cost-effectiveness analysis between acupuncture and artificial tear drop treatment (additional study)
[Time Frame: Up to 13 weeks]
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General Assessment by acupuncture practitioner and participants
[Time Frame: Up to 5 weeks]
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Qualitative analysis (additional study)
[Time Frame: Up to 13 weeks]
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Quality of life (QOL)
[Time Frame: Up to 13 weeks]
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Schirmer I test with anaesthesia
[Time Frame: Up to 13 weeks]
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Self reports about experiences of using other dry eye-related treatments after the end of each intervention.
[Time Frame: Up to 13 weeks]
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Tear Film Break Up Time (BUT)
[Time Frame: Up to 13 weeks]
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Visual analogue scale (VAS) for self-assessment of ocular discomfort
[Time Frame: Up to 13 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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