search
Back to results

Acupuncture Treatment of Dry Eye

Primary Purpose

Keratoconjunctivitis Sicca, Xeropthalmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
Walter Reed Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Acupuncture

Sham Acupuncture

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2007
Last Updated
August 26, 2011
Sponsor
Walter Reed Army Medical Center
Collaborators
Malcolm Grow Medical Clinics and Surgery Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00554879
Brief Title
Acupuncture Treatment of Dry Eye
Official Title
Acupuncture Treatment of Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Walter Reed Army Medical Center
Collaborators
Malcolm Grow Medical Clinics and Surgery Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca, Xeropthalmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Acupuncture
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham Acupuncture
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mines, MD
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Acupuncture Treatment of Dry Eye

We'll reach out to this number within 24 hrs