Acupuncture Treatment of Dry Eye
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to determine the safety and efficacy of acupuncture in the treatment of moderate to severe dry eye by replicating the study design of the previous protocol and to see the study through to its completion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 6, 2007
CompletedFirst Posted
Study publicly available on registry
November 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 30, 2011
August 1, 2011
3.3 years
November 6, 2007
August 26, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To answer the question of whether there are objective beneficial effects of an acupuncture treatment versus sham acupuncture on dry eye, as measured by some of the most widely-used clinical indicators in the literature.
6 months after acupuncture or sham acupuncture treatment
Study Arms (2)
1
EXPERIMENTALAcupuncture
2
SHAM COMPARATORSham Acupuncture
Interventions
Needles placed bilaterally on the ears at the auriculotherapy points. Additional needles placed in both index fingers. A third set of needles inserted on both index fingers between LI-1 adn LI-2.
Four needles will be placed on the left and right upper shoulder areas. Small circular adhesive tape will be placed in an ear area, but not on the acupuncture points.
Eligibility Criteria
You may qualify if:
- Military healthcare beneficiary
- Male and female patients, at least 18 years of age
- Diagnosis of keratoconjunctivitis sicca or xerophthalmia (dry eyes) in one or both eyes
- Persistent signs and symptoms despite conventional therapy for at least three months
You may not qualify if:
- Contact lens wear
- Intraocular surgery or laser in the study eye within 90 days prior to enrolling in the study
- History of any medical condition or circumstance that would preclude scheduled visits or completion of the study
- Known history of adverse reaction to acupuncture
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Mines, MD
Walter Reed Army Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
November 6, 2007
First Posted
November 7, 2007
Study Start
November 1, 2007
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
August 30, 2011
Record last verified: 2011-08