CompletedPhase 4ACTRN12611000425998

Effects of phytoestrogen supplementation in postmenopausal women with dry eye syndrome: A randomized clinical trial.

Correlation between sex hormone levels and tear film osmolarity and qualitative and quantitative film lacrimal improvement in post menopausal women with dry eye syndrome treated with oral supplementation of phytoestrogen.

Sponsor

ministry of education university and research

Enrollment

66 participants

Start Date

Sep 1, 2009

Study Type

Interventional

Conditions

dry eye syndrome

Summary

The aims of our study were to evaluate the correlation between sex hormone levels and tear film osmolarity in postmenopausal women and to assess the efficacy of an oral phytoestrogen supplement in controlling the ocular symptoms of post-menopausal dysfunctional tear syndrome (DTS).

Eligibility

Sex: FemalesMin Age: 48 Yearss

Plain Language Summary

Simplified for easier understanding

This trial tests whether a phytoestrogen supplement (plant-based oestrogen) can improve dry eye symptoms in postmenopausal women aged 48+. Participants must have severe dry eye syndrome. Women with autoimmune disease, allergy to the supplement's ingredients, or those using anti-inflammatory or antibiotic eye drops are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Sixty-six postmenopausal women with dysfunctional tear syndrome (DTS) were enrolled in a randomized, double-blind, placebo-controlled, cross-over study. Patient were divided into two groups (Group A

Sixty-six postmenopausal women with dysfunctional tear syndrome (DTS) were enrolled in a randomized, double-blind, placebo-controlled, cross-over study. Patient were divided into two groups (Group A and Group B) and treated respectively with Lacrisek ( alpha lipoic acid100mg,phytoestrogen 200mg, fish oil 240mg),Registered Trademark, tablets or placebo tablets, twice a day for 30 days. The two treatment periods were separated by a 30-day washout. Patients were examined on day 0 and day 30 of each period. Assessments included blood levels of sex hormones, the Schirmer test for tear production, and measurement of tear osmolarity and tear film break-time (T-BUT).

Locations(1)

Italy

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ACTRN12611000425998