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Acupuncture Treatment of Dry Eye

This study has been completed.
Sponsor:
Collaborator:
Malcolm Grow USAF Medical Center
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00554879
First received: November 6, 2007
Last updated: August 26, 2011
Last verified: August 2011
History of Changes

November 6, 2007
August 26, 2011
November 2007
February 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: 6 months after acupuncture or sham acupuncture treatment ] [ Designated as safety issue: No ]
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. [ Time Frame: 6 months after acupuncture or sham acupuncture treatment ]
Complete list of historical versions of study NCT00554879 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acupuncture Treatment of Dry Eye
Acupuncture Treatment of Dry Eye

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Keratoconjunctivitis Sicca
  • Xeropthalmia
  • Procedure: Acupuncture
    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.
  • Procedure: Sham acupuncture
    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.
  • Experimental: 1
    Acupuncture
    Intervention: Procedure: Acupuncture
  • Sham Comparator: 2
    Sham Acupuncture
    Intervention: Procedure: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554879
WU # 07-23024
Yes
Michael J. Mines, Walter Reed Army Medical Center
Walter Reed Army Medical Center
Malcolm Grow USAF Medical Center
Principal Investigator: Michael J Mines, MD Walter Reed Army Medical Center
Walter Reed Army Medical Center
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP