Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000425998
Ethics application status
Approved
Date submitted
16/04/2011
Date registered
27/04/2011
Date last updated
27/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of phytoestrogen supplementation in postmenopausal women with dry eye syndrome: A randomized clinical trial.
Scientific title
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.
Secondary ID [1] 259850 0
' Nil'
Universal Trial Number (UTN)
U1111-1120-1990
Trial acronym
DES (dry eye syndrome)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dry eye syndrome 265426 0
Condition category
Condition code
Eye 265586 265586 0 0
Diseases / disorders of the eye
Other 265587 265587 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 264268 0
Treatment: Other
Intervention code [2] 264435 0
Treatment: Drugs
Comparator / control treatment
placebo twice a day, oral methylcellulose tablets
Control group
Placebo

Outcomes
Primary outcome [1] 262382 0
to assess the efficacy of an oral phytoestrogen supplement in controlling the ocular symptoms of post-menopausal Assessments included blood levels of sex hormones, the Schirmer test for tear production, measurement of tear osmolarity and tear film break-time (T-BUT)
Timepoint [1] 262382 0
at baseline,at 30 day after intervention
Secondary outcome [1] 273668 0
To asses that improvement of tear film function is limited in time. We valued Schirmer test,T-BUT (tear film break-up time), Tear osmolarty after 30 days after discontinuation of theraphy with Lacrisek.
Timepoint [1] 273668 0
after 30 day of intervention

Eligibility
Key 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.
Minimum age
48 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computerizated randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomizated table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 3315 0
Italy
State/province [1] 3315 0

Funding & Sponsors
Funding source category [1] 264725 0
University
Name [1] 264725 0
"sapienza"
Country [1] 264725 0
Italy
Primary sponsor type
Government body
Name
ministry of education university and research
Address
viale trastevere 76 roma 00100
Country
Italy
Secondary sponsor category [1] 263851 0
None
Name [1] 263851 0
Address [1] 263851 0
Country [1] 263851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266863 0
Vittorio Emanuele University Catania
Ethics committee address [1] 266863 0
Ethics committee country [1] 266863 0
Italy
Date submitted for ethics approval [1] 266863 0
Approval date [1] 266863 0
01/06/2009
Ethics approval number [1] 266863 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32380 0
Address 32380 0
Country 32380 0
Phone 32380 0
Fax 32380 0
Email 32380 0
Contact person for public queries
Name 15627 0
Iacovello Daniela
Address 15627 0
via di grottarossa 1035-1039
00189 Rome
Country 15627 0
Italy
Phone 15627 0
+39-3494682907
Fax 15627 0
+39-06-33776602
Email 15627 0
[email protected]
Contact person for scientific queries
Name 6555 0
Iacovello Daniela
Address 6555 0
via di grottarossa 1035-1039
00189 Rome
Country 6555 0
Italy
Phone 6555 0
+39-3494682907
Fax 6555 0
+39-06-33776602
Email 6555 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.