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Acupuncture Treatment of Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00554879
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : August 30, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Keratoconjunctivitis Sicca Xeropthalmia Procedure: Acupuncture Procedure: Sham acupuncture

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment of Dry Eye
Study Start Date : November 2007
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Acupuncture
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.
Sham Comparator: 2
Sham Acupuncture
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.


Outcome Measures

Primary Outcome Measures :
  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. [ Time Frame: 6 months after acupuncture or sham acupuncture treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554879


Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington DC, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Malcolm Grow Medical Clinics and Surgery Center
Investigators
Principal Investigator: Michael J Mines, MD Walter Reed Army Medical Center
More Information

Responsible Party: Michael J. Mines, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00554879     History of Changes
Other Study ID Numbers: WU # 07-23024
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases