Acupuncture Treatment of Dry Eye - Tabular View

Tracking Information

First Received Date ^ICMJE

November 6, 2007

Last Updated Date

February 11, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00554879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Acupuncture Treatment of Dry Eye

Official Title ^ICMJE

Acupuncture Treatment of Dry Eye

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment

Condition ^ICMJE

Keratoconjunctivitis Sicca
Xeropthalmia

Intervention ^ICMJE

Procedure: Acupuncture
Procedure: Sham acupuncture

Study Arms / Comparison Groups

Experimental: Acupuncture
Sham Comparator: Sham Acupuncture

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

September 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kraig S Bower, MD

202-782-0202

kraig.bower@na.amedd.army.mil

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00554879

Responsible Party

KRAIG S. BOWER, MD, Walter Reed Army Medical Center

Study ID Numbers ^ICMJE

WU # 07-23024

Study Sponsor ^ICMJE

Walter Reed Army Medical Center

Collaborators ^ICMJE

Malcolm Grow USAF Medical Center

Investigators ^ICMJE

Principal Investigator:

Kraig S Bower, MD

Walter Reed Army Medical Center

Information Provided By

Walter Reed Army Medical Center

Verification Date

November 2007

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