Herbal Medication to Treat Dry Eye in Peri/ Post-menopausal Women

NCT05319041 | Completed Early Phase 1

• 2 other identifiers: R1675/72/20192019/2957
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 medicine. This will keep the care affordable and accessible despite a large burden of care. Postmenopausal women, compared to others in the population, have a higher incidence of DED. Large-scale epidemiological studies done in the United States have shown that the rate of DED in women over 50 years old is nearly double that in men over 50, at 7% and 4%, respectively. Studies have demonstrated that there is a hormonal etiology behind this group's susceptibility to DED, although the precise hormonal imbalance and mechanistic pathway for DED are still unclear. A significant number of women seen at the dry eye clinic are post-menopausal, and very symptomatic, though many do not have the corneal epitheliopathy evidenced by dye staining. Such patients are not likely to benefit from conventional prescription drugs for dry eye, such as cyclosporine and corticosteroids. Hormonal replacement therapy for menopausal women has not been universally accepted, and there may be an increased risk of carcinomas, on the other hand, topical hormonal therapy for dry eye is not widely available, and still controversial, so there is a definite unmet need for new therapeutic modalities to treat dry eye in post-menopausal women. Traditional Chinese Medicine (TCM) is a form of complementary medicine that aims to treat yin or yang deficiency syndromes, using modalities like herbs, acupuncture or moxibustion. Menopause in women, particularly in Asia, has been linked to yin-deficiency, in one study, 73% of Chinese post-menopausal women suffered from kidney yin-deficiency. A review of randomized controlled trials of TCM treatment showed that certain modalities like soy and phytoestrogens have been useful in the treatment of syndromes in menopause, such as hot flushes.

Conditions

Dry Eye

Keywords

Menopausal women; Herbal treatment; Quality of Life; eicosanoids; cytokines

Outcome Measures

Primary Outcomes (1)

• Change in SPEED score

  To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic)

  3 months

Secondary Outcomes (4)

• Change in SPEED score

  4 months

• Change in Sleep score

  3 months

• Change in Depression score

  3 months

• Change in TCM score (Liver-Kidney Yin Deficiency)

  3 months

Study Arms (2)

Active herbal capsules

EXPERIMENTAL

Wei's Qi Ju Gan Lu Formula is a herbal formulation initiated by the senior TCM collaborator, Prof Wei QP. This TCM formulation is prescribed to treat the dry eye patients with "liver-kidney yin deficiency". The treatment regulation aims to nourish the Liver and Kidney, enrich yin deficiency, in order to promote tears production, hence treatment of Dry Eye.

Drug: Wei's Qi Ju Gan Lu Formula

Placebo capsules

PLACEBO COMPARATOR

Placebo capsule which contains 0.5g maltodextrin without any herbs medicine.

Drug: Placebo

Interventions

Wei's Qi Ju Gan Lu Formula DRUG

The formulation, Wei's Qi Ju Gan Lu Formula, is initiated by the senior TCM collaborator, Prof Wei QP, is formulated to treat the dry eye patients with "liver-kidney yin deficiency". The treatment regulation aims to nourish the Liver and Kidney, enrich yin deficiency, in order to promote tears production, hence treatment of Dry Eye.

Active herbal capsules

Placebo DRUG

0.5g maltodextrin without any herbs medicine

Also known as: 0.5g maltodextrin without any herbs medicine

Placebo capsules

Eligibility Criteria

• Age: 40 Years - 79 Years
• Gender Eligibility Details: Peri and Post-menopausal women age between 40-79 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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:
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Singapore Chung Hwa Medical Institution: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Louis Tong, PhD

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: April 11, 2022
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)