Keratoconjunctivitis SiccaNCT00554879
Acupuncture Treatment of Dry Eye
A study testing Acupuncture in people with Keratoconjunctivitis Sicca and Xeropthalmia, run by Walter Reed Army Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconjunctivitis Sicca, Xeropthalmia
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
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.
- Conditions
- Keratoconjunctivitis Sicca, Xeropthalmia
- Being tested
- Acupuncture, Sham acupuncture
- Medical subject headings
- Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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 acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Acupuncture Receives: Procedure: Acupuncture |
| 2 | Sham comparator | Sham Acupuncture Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after acupuncture or sham acupuncture treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Malcolm Grow Medical Clinics and Surgery Center
- Investigators
- Michael J Mines, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554879
- Sponsor's protocol ID
- WU # 07-23024
- Status last verified
- Aug 2011
- First submitted
- 6 Nov 2007
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT00554879
- Acronym / sponsor ID
- WU # 07-23024
- Conditions
- Keratoconjunctivitis Sicca, Xeropthalmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- Malcolm Grow Medical Clinics and Surgery Center
- Study start
- Nov 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: AcupunctureAcupuncture |
| 2 | Sham comparator | Procedure: Sham acupunctureSham Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureNeedles 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 or surgery | 1 |
| Sham acupunctureFour 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. | Procedure or surgery | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
Related trials for Keratoconjunctivitis Sicca
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mines, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Keratoconjunctivitis Sicca and Xeropthalmia, run by Walter Reed Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.