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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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|
- Change in SPEED score (Week4-Week0) [ Time Frame: 4 weeks ]Any improvement or discomfort in dry eye symptoms during 4 weeks
- Change in Tear Evaporimetry [ Time Frame: 4 weeks ]
- Change in TCM score (Lung-Kidney Yin deficiency) [ Time Frame: 4 weeks ]
- Change in Non Invasive Break Up Time [ Time Frame: 4 weeks ]
- Change in Schirmers I [ Time Frame: 4 weeks ]
- Change in Corneal fluorescein staining [ Time Frame: 4 weeks ]
- Change in Tear osmolarity [ Time Frame: 4 weeks ]
- Change in Tear meniscus height [ Time Frame: 4 weeks ]
- Change in Tear protein/ cytokine levels [ Time Frame: 4 weeks ]
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
|Singapore National Eye Centre/ Singapore Eye Research Institute|
|Singapore, Type a choice below ..., Singapore, 168751|
|Principal Investigator:||Louis Tong, PhD||Singapore National Eye Centre|