Acupuncture Treatment of Dry Eye - Full Text View

Sponsor:	Walter Reed Army Medical Center
Collaborator:	Malcolm Grow USAF Medical Center
Information provided by:	Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:	NCT00554879

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:

MedlinePlus related topics: Acupuncture Acute Bronchitis

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 February 09, 2012