Phase 3
N=42
Acupuncture for Dry Eye Syndrome
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00969280 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Ocular Surface Disease Index : OSDI — -17.61; -17.20 Scores on the OSDI score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standardized Acupuncture (Device); Non-acupuncture point shallow penetration acupuncture (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Korea Institute of Oriental Medicine
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Surface Disease Index : OSDI |
-17.61; -17.20 | — |
| SECONDARY Visual Analogue Scale of Self Symptoms |
— | — |
| SECONDARY Schirmer 1 Test |
— | — |
| SECONDARY Tear Film Break-up Time : BUT |
— | — |
| SECONDARY Medication Quantification Scale (MQS) |
— | — |
| SECONDARY General Assessment |
— | — |
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:
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00969280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.