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Trial registered on ANZCTR


Registration number
ACTRN12612000281897
Ethics application status
Approved
Date submitted
5/03/2012
Date registered
9/03/2012
Date last updated
31/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Testosterone and Oestradiol Therapy on Clinical Indices and Biomarkers of Dry Eye in Post Menopausal Women
Scientific title
In post menopausal women, does administration of Estradot 50mcg patches twice weekly and/or Andro-Feme cream, 1/2ml daily, for eight weeks, compared to placebo improve dry eye clinical indices and biomarkers
Secondary ID [1] 280078 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye 285989 0
Condition category
Condition code
Eye 286178 286178 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Andro-Feme (Testosterone) cream, 1/2ml daily for 8 weeks
Arm 2: Estradot (Oestradiol) 50mcg patches twice weekly for 8 weeks
Arm 3: Combination of Anro-Feme and Estradot (as above)for 8 weeks
Arm 4: Placebo patch and cream for 8 weeks
Intervention code [1] 284401 0
Treatment: Drugs
Comparator / control treatment
Inactive placebo patch and cream
Control group
Placebo

Outcomes
Primary outcome [1] 286643 0
Primary Outcome 1: Subjective ocular and systemic symptoms assessed using validated questionnaires
Timepoint [1] 286643 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [1] 296365 0
Secondary Outcome 1: Quality of Life measurement as assessed using validated questionnaires
Timepoint [1] 296365 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [2] 296427 0
Secondary Outcome 2: Tear osmolarity using Ocusense TearLab Osmolality System
Timepoint [2] 296427 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [3] 296428 0
Secondary Outcome 3: Tear volume using Phenol Red Thread/Schirmer Test
Timepoint [3] 296428 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [4] 296429 0
Secondary Outcome 4: Tear stability using Keeler Tearscope
Timepoint [4] 296429 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [5] 296430 0
Secondary Outcome 5: Tear protein content using Multiple reaction monitoring mass spectometry (MRM-MS)
Timepoint [5] 296430 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [6] 296431 0
Secondary Outcome 6:Ocular surface sensitivity using Cochet-Bonnet aesthesiometer
Timepoint [6] 296431 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [7] 296432 0
Secondary Outcome 7: Ocular surface integrity using Sodium Fluorescein Dye and Lissamine Green Dye with Modified Oxford Grading Scale
Timepoint [7] 296432 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [8] 296433 0
Secondary Outcome 8: Meibomian gland appearance using (Modified Bron Grading Scale)
Timepoint [8] 296433 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [9] 296434 0
Secondary Outcome 9 : Circulating hormone levels using ELISA kits from DRG International, USA
Timepoint [9] 296434 0
Timepoint: at baseline and at 8 weeks after intervention commencement
Secondary outcome [10] 296435 0
Secondary Outcome 10: Conjunctival redness using slit-lamp biomicroscopy
Timepoint [10] 296435 0
Timepoint: at baseline and at 8 weeks after intervention commencement

Eligibility
Key inclusion criteria
Post menopausal women who has permanent cessation of menses for at least one year with dry eye
Minimum age
50 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Experience normal menstrual cycle
History of corneal or refractive surgery
Diagnosis of Sjogren’s Syndrome
History of hormone therapy within the past 12 months
Prior diagnosis of infectious disease transmittable by blood (eg HIV/AIDS, Hepatitis)
Eye surgery within 6 months immediately prior to enrolment for this study

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)
Neither the investigator nor the subject shall be masked. Allocation is concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
80 subjects randomized using the seed 17132 from randomized.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284831 0
University
Name [1] 284831 0
School of Optometry and Vision Science
Address [1] 284831 0
University of New South Wales, Sydney, NSW 2052
Country [1] 284831 0
Australia
Primary sponsor type
University
Name
School of Optometry and Vision Science
Address
University of New South Wales, Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 283709 0
None
Name [1] 283709 0
Address [1] 283709 0
Country [1] 283709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286820 0
Human Research Ethics Committee UNSW
Ethics committee address [1] 286820 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3 (M15)
University of New South Wales NSW 2052
Ethics committee country [1] 286820 0
Australia
Date submitted for ethics approval [1] 286820 0
06/03/2012
Approval date [1] 286820 0
Ethics approval number [1] 286820 0
#HC12087

Summary
Brief summary
This project will investigate the effect of restoration of transdermal Testosterone and Oestrogen on dry eye clinical indicators and biomarkers in post menopausal women. Association between these sex hormones levels and the measured parameters might be elucidated while suggesting for an option of dry eye treatment in this population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33869 0
Address 33869 0
Country 33869 0
Phone 33869 0
Fax 33869 0
Email 33869 0
Contact person for public queries
Name 17116 0
Noor Ezailina Badarudin
Address 17116 0
School of Optometry and Vision Science
University of New South Wales, Sydney, NSW 2052
Country 17116 0
Australia
Phone 17116 0
+61 2 9385-4536
Fax 17116 0
+61 2 9313-6243
Email 17116 0
N.Badarudin@student.unsw.edu.au
Contact person for scientific queries
Name 8044 0
Dr Blanka Golebiowski
Address 8044 0
School of Optometry and Vision Science
University of New South Wales, Sydney, NSW 2052
Country 8044 0
Australia
Phone 8044 0
+61 2 9385-4502
Fax 8044 0
+61 2 9313-6243
Email 8044 0
b.golebiowski@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results