NCT02219204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 5, 2016

Status Verified

February 1, 2016

Enrollment Period

9 months

First QC Date

August 14, 2014

Last Update Submit

August 3, 2016

Conditions

Dry Eye

Keywords

AcupunctureHerbal treatment

Outcome Measures

Primary Outcomes (1)

  • Change in SPEED score (Week4-Week0)

    Any improvement or discomfort in dry eye symptoms during 4 weeks

    4 weeks

Secondary Outcomes (8)

  • Change in Tear Evaporimetry

    4 weeks

  • Change in TCM score (Lung-Kidney Yin deficiency)

    4 weeks

  • Change in Non Invasive Break Up Time

    4 weeks

  • Change in Schirmers I

    4 weeks

  • Change in Corneal fluorescein staining

    4 weeks

  • +3 more secondary outcomes

Study Arms (3)

Acupuncture treatment

ACTIVE COMPARATOR

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

Herbal treatment

ACTIVE COMPARATOR

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

Eye drops

NO INTERVENTION

Interventions

AcupuncturePROCEDURE
Acupuncture treatment
Herbal treatmentOTHER
Herbal treatment

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • Trichiasis
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre/ Singapore Eye Research Institute

Singapore, Type A Choice Below ..., 168751, Singapore

Location

Related Publications (1)

  • Tong L, Htoon HM, Hou A, Acharya RU, Tan JH, Wei QP, Lim P. Acupuncture and herbal formulation compared with artificial tears alone: evaluation of dry eye symptoms and associated tests in randomised clinical trial. BMJ Open Ophthalmol. 2018 Jun 18;3(1):e000150. doi: 10.1136/bmjophth-2018-000150. eCollection 2018.

    PMID: 30123846DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Louis Tong, PhD

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist, Senior Consultant

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 18, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 5, 2016

Record last verified: 2016-02

Locations

SG(1)