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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000425998
Acronym
DES (dry eye syndrome)
Enrollment
66
Registered
2011-04-27
Start date
2009-09-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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).

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 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 ea

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).

Sponsors

ministry of education university and research
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
48 Years to No maximum
Healthy volunteers
No

Inclusion criteria

menopause and severe dry eye syndrome. Dry eye syndrome is defined as a multifactorial disorder caused by one chronic inflammatory status due to tear film disequilibrium, main symptoms are: photophobia, visual disturbance, extraneous body sensation, difficulties in eye opening at the morning.

Exclusion criteria

Hypersensitivity to one of components of the phytoestrogen supplement being tested, autoimmune disease, and current use of topical anti-inflammatory and/or antibiotic eye therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026