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Randomised Research Comparing Acupuncture, Herbal Treatment and Artificial Tear Eye Drops in Dry Eye

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ClinicalTrials.gov Identifier: NCT02219204
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:

Dry eye is a major, common medical condition with significant health and economic burden in Singapore and worldwide. It is a holistic problem affected by living habits, nutrition and underlying systemic disease, inducing a significant decrease in quality-of-life. The hallmark of this disease is raised tear osmolarity and inflammation. There is no definitive cure for this condition, as treatment in the form of lubricants is only symptomatic and treatment with cyclosporine eyedrops is expensive and may not be well tolerated.

Following the rise in international interest in complementary medicine, randomized-controlled studies in dry eye using Traditional Chinese Medicine (TCM) have been published, with mixed results. However, the major limitation of these studies is the lack of objective assessment for inflammation.

We propose to collaborate with an academically-trained Singapore TCM physician who has conducted dry eye trials, and synergistically exploit the existing state-of-the-art dry eye monitoring technologies available at Singapore Eye Research Institute (SERI). This proposal is cost-effective, building on previous government grants and expertise to provide definitive scientific evidence on the efficacy and safety of TCM in dry eye. SERI has an international reputation for interventional studies, and the PI has a good academic relationship with the above TCM physician. We propose to screen, recruit and treat 150 patients with a herbal preparation and acupuncture, and evaluate over 4 weeks in a randomized-controlled study. Tests to be performed will include tear imaging and osmolarity, as well as protein and cytokine assays.

Singapore is uniquely positioned at the crossroads of the East and the West to take the lead in this field. Given that there is an increasing patient interest in holistic care in Singapore and the rise of scientifically trained TCM practitioners, a study like this one is very timely, and will have tremendous impact to healthcare delivery in Singapore.


Condition or disease Intervention/treatment Phase
Dry Eye Procedure: Acupuncture Other: Herbal treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomised Research Comparing Acupuncture, Herbal Treatment and Artificial Tear Eye Drops in Dry Eye
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Tears

Arm Intervention/treatment
Active Comparator: Acupuncture treatment

This will be performed twice weekly for 30 days. There will be 8 sessions of acupuncture treatments in total.

The needles to be use around the eyes will have the dimensions of 0.25 (diameter) x 13mm (length), while 0.25 x 25mm needles will be used behind the ear (feng chi) and 0.30 X 25mm needles on the upper and lower limbs. These needles will remain in the points for 20 minutes. The depth of penetration will be about 1-2 mm.

Procedure: Acupuncture
Active Comparator: Herbal treatment
This formulation is called qi ju gan lu yin or Lycium berry, a chrysanthemum beverage. This is a modified version of "qi ju di huang wan" published previously. The senior TCM collaborator, Prof Wei QP has made this modification in order to treat the dry eye patients with "lung-kidney yin deficiency".
Other: Herbal treatment
No Intervention: Eye drops



Primary Outcome Measures :
  1. Change in SPEED score (Week4-Week0) [ Time Frame: 4 weeks ]
    Any improvement or discomfort in dry eye symptoms during 4 weeks


Secondary Outcome Measures :
  1. Change in Tear Evaporimetry [ Time Frame: 4 weeks ]
  2. Change in TCM score (Lung-Kidney Yin deficiency) [ Time Frame: 4 weeks ]
  3. Change in Non Invasive Break Up Time [ Time Frame: 4 weeks ]
  4. Change in Schirmers I [ Time Frame: 4 weeks ]
  5. Change in Corneal fluorescein staining [ Time Frame: 4 weeks ]
  6. Change in Tear osmolarity [ Time Frame: 4 weeks ]
  7. Change in Tear meniscus height [ Time Frame: 4 weeks ]
  8. Change in Tear protein/ cytokine levels [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 40-85 years, visual acuity better than logMAR of 1.0
  2. Chief complaint should be dry eye
  3. Symptoms:

    3.1. SPEED score > 6

    3.2. TCM score satisfies lung-kidney yin deficiency profile

  4. Signs:

4.1. TBUT (<10s) or Schirmer's test (<10mm/5 mins) 4.2 Any corneal fluorescein staining

Exclusion Criteria:

  1. Glaucoma or other ophthalmic disease, eg. Extraocular muscle palsies, ectropion, entropion
  2. Ocular allergies, eg. Allergic conjunctivitis, sinusitis, eczema, atopic keratoconjuntivitis
  3. Known of thyroid disorders (diagnosed by physician)
  4. Trichiasis
  5. Eye surgeries patients including LASIK (within 1 year)
  6. Steven-Johnson syndrome
  7. Sjogren's syndrome
  8. Eye related trauma (within 1 year)
  9. Contact lens wear (within 1 year)
  10. Punctal occlusion
  11. Systemic disease requiring regular medication (except hypertension and lipidemia)
  12. Pregnancy or planning to be pregnant
  13. Requirement for medications such as anti-microbial, inflammatory, creams (except moisturizers or cosmetics), or steroidal therapies
  14. Unable to do this clinical trial for any reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219204


Locations
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Singapore
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Type a choice below ..., Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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Principal Investigator: Louis Tong, PhD Singapore National Eye Centre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT02219204     History of Changes
Other Study ID Numbers: R1142/44/2014
2014/398/A ( Other Identifier: SingHealth Centralised Institutional Review Board )
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: February 2016

Keywords provided by Louis Tong, Singapore National Eye Centre:
Acupuncture
Herbal treatment

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions