Acupuncture Treatment of Dry Eye

Sponsor

Walter Reed Army Medical Center (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00554879

Collaborator

Malcolm Grow Medical Clinics and Surgery Center (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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	Phase
Keratoconjunctivitis Sicca Xeropthalmia	Procedure: Acupuncture Procedure: Sham acupuncture	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2007

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

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.

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00554879

Other Study ID Numbers:

WU # 07-23024

First Posted:

Nov 7, 2007

Last Update Posted:

Aug 30, 2011

Last Verified:

Aug 1, 2011

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Aug 30, 2011