Acupuncture Treatment of Dry Eye

Keratoconjunctivitis Sicca Clinical Trial

Official title:

Acupuncture Treatment of Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554879
• Other study ID #: WU # 07-23024
• Status: Completed
• Phase: N/A
• First received: November 6, 2007
• Last updated: August 26, 2011
• Start date: November 2007
• Est. completion date: February 2011

Study information

• Verified date: August 2011
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca
• Xeropthalmia

Intervention

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 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.

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington DC	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center	Malcolm Grow Medical Clinics and Surgery Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No