Status:
COMPLETED
Herbal Medication to Treat Dry Eye in Peri/ Post-menopausal Women
Lead Sponsor:
Singapore National Eye Centre
Collaborating Sponsors:
Singapore Chung Hwa Medical Institution
Conditions:
Dry Eye
Eligibility:
FEMALE
40-79 years
Phase:
EARLY_PHASE1
Brief Summary
Dry eye disease (DED) in less severe forms are very common, and should ideally be treated outside hospitals, eg., through primary care services and exploiting holistic therapies such as traditional me...
Detailed Description
The overall hypothesis is that the Traditional Chinese Medicine (TCM) modality of a specific herbal formulation can improve the symptoms and signs of post-menopausal dry eye in women, and objectively,...
Eligibility Criteria
Inclusion
- Age 40-79 years old women
- Peri and Post-menopausal women
- Chief complaint of participant should be consistent with dry eye symptoms based on SPEED Questionnaire, with a score of \> 6 (Appendix 5)
- History of presenting TCM score symptoms:
- 1. TCM dry eye assessment score (Appendix 3) The pattern deviation can be determined if 3 or more main symptoms are present (one of which is a localized eye symptom and one of which is a system symptom), together with at least one accompanying symptom.
- 2 Liver-Kidney yin deficiency assessment score (Appendix 4) This form is to determine the extent of Liver-Kidney Yin Deficiency (assessed at SCHMI).
- Any score\<14 will not satisfy the criterion for Liver Kidney Yin Deficiency and will not be recruited. This detailed TCM score will also be a secondary outcome measure in the analysis of pre/post herbal treatment (see below).
- Clinical signs:
- 1. Tear break up time (TBUT) ≤10s or Schirmer I test ≤10mm/5 mins
- Normal renal and liver function at baseline, i.e., all parameters within the reference value
Exclusion
- Currently or intention to use hormonal therapy (eg. cancer patients who is on tamoxifen)
- Currently pregnant or breastfeeding
- Hysterectomy procedure done previously
- Removal of cysts or polyp procedure done previously
- Requirement to wear contact lens, and having worn such lenses in week preceding eligibility
- Glaucoma, significant cataract, age related macular degeneration or other ophthalmic disease, eg. Extraocular muscle palsies, facial paralysis, ectropion, entropion, trichiasis
- Requirement of any eyedrops other than artificial tears.
- Previous eye surgeries including LASIK (within 6 months) or punctal plugs in-situ
- Autoimmune systemic diseases: Steven-Johnson syndrome, Sjogren's syndrome, Rheumatoid Arthritis, Lupus
- Systemic disease requiring regular medication (except hypertension and lipidemia)
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05319041
Start Date
April 11 2022
End Date
February 21 2025
Last Update
May 15 2025
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore