Acupuncture Treatment of Dry Eye

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: February 2011

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: 1
    • Acupuncture
  • Sham Comparator: 2
    • Sham Acupuncture

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Walter Reed Army Medical Center
  • Collaborator
    • Malcolm Grow Medical Clinics and Surgery Center
  • Provider of Information About this Clinical Study
    • Michael J. Mines, Walter Reed Army Medical Center
  • Overall Official(s)
    • Michael J Mines, MD, Principal Investigator, Walter Reed Army Medical Center

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