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

What this trial studies

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.

Conditions in scope

• Dry Eye

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,…
• Placebo (Drug) — 0.5g maltodextrin without any herbs medicine

Who can join

Women only · Ages 40 Years to 79 Years · Accepts healthy volunteers.

Inclusion criteria

• 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:

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: EARLY_PHASE1
• Start date: 2022-04-11
• Primary completion: 2025-02-21
• Last update posted: 2025-05-15
• First posted: 2022-04-08

Sponsor & contact

Lead sponsor: Singapore National Eye Centre (Other Gov)

Collaborators: Singapore Chung Hwa Medical Institution

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in SPEED score (3 months)
  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)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.