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临床试验/NCT02219204
NCT02219204已完成不适用

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

Singapore National Eye Centre2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Change in SPEED score (Week4-Week0)

研究概览

简要总结

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.

详细描述

Dry eye is a major, common medical condition with significant health burden in Singapore and worldwide. As much as one third of the adult population in Asian countries are affected by dry eye. It has been shown that dry eye affects quality of life, including the performing of daily activities such as reading and driving a car. Moderate severity of dry eye affects some patients like moderate angina. The direct and indirect cost of treating dry eye is high and increasing. For example, it costs individuals about US$800 per year to treat dry eye, but the cost to society for managing such a patient is US$12000 per year. (1-29)

Dry eye is a holistic problem affected by living habits such as working long hours on the computer and in a dry, air-conditioned environment. It is also associated with poor nutrition and intake of dietary supplements such as omega-3 and omega-6 fatty acids may help to treat dry eye. Dry eye is also a systemic immune mediated disease, and aggravated by those with autoimmune Sjögren's syndrome, rheumatoid arthritis, thyroid disease, systemic lupus erythematosis, Steven Johnson syndrome and chronic graft versus host disease.

In a recent international workshop, international experts in dry eye agree that the hallmark of this disease is raised tear osmolarity and ocular surface inflammation. Traditionally, dry eye is diagnosed by a reduced Schirmer's test and/or reduced tear break up time or the presence of dry eye symptoms. In addition to these traditional tests, it would be advantageous to incorporate measurements of osmolarity and inflammation in clinical studies. There is no definitive cure for this condition, as treatment in the form of lubricants is only symptomatic and treatment with cyclosporine eye drops is expensive and may not be well tolerated. Treatment with steroids can be effective but associated with adverse effects such as sight threatening glaucoma. In summary there is a definite medical need for alternative therapies in dry eye.

Traditional Chinese Medicine (TCM) is involved in restoring the natural balance of the body, which results in disease like dry eye when this is disturbed. In TCM philosophy, dry eye may result from syndromes such as yin deficiency in the liver or kidney. Modalities such as acupuncture or herbs can be used judiciously to restore the balance in specific patients.

Recently there have been randomized controlled studies in dry eye using acupuncture and herbs, with mixed results, refer to attachment (Table 1). The major limitation of these studies is that objective tear film evaluation such as tear osmolarity, and tear cytokines and proteins, which are indicative of ocular surface inflammation, have not been evaluated. In addition, some studies suffer from lack of proper controls or randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 40-85 years, visual acuity better than logMAR of 1.0
  • Chief complaint should be dry eye
  • SPEED score > 6
  • TCM score satisfies lung-kidney yin deficiency profile
  • TBUT (<10s) or Schirmer's test (<10mm/5 mins) 4.2 Any corneal fluorescein staining

排除标准

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

结局指标

主要结局

Change in SPEED score (Week4-Week0)

时间窗: 4 weeks

Any improvement or discomfort in dry eye symptoms during 4 weeks

次要结局

  • Change in Tear meniscus height(4 weeks)
  • Change in Tear protein/ cytokine levels(4 weeks)
  • Change in Tear Evaporimetry(4 weeks)
  • Change in TCM score (Lung-Kidney Yin deficiency)(4 weeks)
  • Change in Corneal fluorescein staining(4 weeks)
  • Change in Tear osmolarity(4 weeks)
  • Change in Non Invasive Break Up Time(4 weeks)
  • Change in Schirmers I(4 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Louis Tong

Clinician-Scientist, Senior Consultant

Singapore National Eye Centre

研究点 (2)

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