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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
  Purpose

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 Intervention
Keratoconjunctivitis Sicca
Xeropthalmia
 Procedure: Acupuncture
Procedure: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment of Dry Eye

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 USAF Medical Center
Investigators
Principal Investigator: Michael J Mines, MD Walter Reed Army Medical Center
  More Information

No publications provided

Responsible Party: Michael J. Mines, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00554879     History of Changes
Other Study ID Numbers: WU # 07-23024
Study First Received: November 6, 2007
Last Updated: August 26, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on June 17, 2013