Acupuncture Treatment of Dry Eye

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.

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca; Xeropthalmia
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham acupuncture

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Walter Reed Army Medical Center
• Collaborators: Malcolm Grow Medical Clinics and Surgery Center

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 6, 2007
• First Submitted That Met QC Criteria: November 6, 2007
• First Posted (Estimate): November 7, 2007

Study Record Updates

• Last Update Posted (Estimate): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
• Other Study ID Numbers: WU # 07-23024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No