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The effects of transdermal testosterone and oestrogen therapy on dry eye in postmenopausal women: a randomised, placebo-controlled, pilot study
  1. Blanka Golebiowski1,
  2. Noor Badarudin1,
  3. John Eden2,3,
  4. Leanne Gerrand1,
  5. Jennifer Robinson1,
  6. Jinzhu Liu2,
  7. Ulrike Hampel1,4,
  8. Jingjing You1,5,
  9. Fiona Stapleton1
  1. 1School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia
  2. 2Sydney Menopause Centre, Royal Hospital for Women, Randwick, New South Wales, Australia
  3. 3School of Women's and Children's Health, UNSW Australia, Sydney, New South Wales, Australia
  4. 4Department of Ophthalmology, University Medical Center of the Johannes Gutenberg-University Mainz, Germany
  5. 5Save Sight Institute, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Dr Blanka Golebiowski, School of Optometry and Vision Science, UNSW Australia, Sydney, NSW 2052, Australia; b.golebiowski{at}unsw.edu.au

Abstract

Aims Sex hormones could provide a future treatment avenue for dry eye post menopause. However, there are few well-controlled studies. This study investigates the impact of testosterone and oestrogen on dry eye symptoms and signs in postmenopausal women.

Methods A randomised double-blind placebo-controlled pilot study was conducted involving 40 women with dry eye (age 63.9±5.1 years, 13.2±6.3 years post menopause). Ten women were assigned to each of four treatment groups: transdermal testosterone, oestradiol, testosterone/oestradiol combination and placebo. Assessment at baseline and after 8 weeks: ocular symptoms, tear osmolarity, tear stability, tear secretion, meibomian gland assessment, corneal and conjunctival sensitivity, serum concentrations of 17β-oestradiol, 3-α-androstanediol-glucuronide and dehydroepiandrosterone sulfate. Differences from placebo were examined using one-way analysis of variance and Dunnett's t-test. Within-group analyses included paired t-tests and Spearman correlation.

Results Dryness intensity after 8 weeks was significantly worse in the oestrogen group compared with placebo (p=0.04). No significant changes in other symptoms, tear function, meibomian gland function, lid morphology, corneal or conjunctival sensitivity were observed in any of the groups when compared with the change in placebo after 8 weeks. Within-group analyses showed increased tear secretion in the testosterone/oestradiol combination group (p=0.03) and a strong association between increased serum androgen and improved tear stability in the testosterone group (ρ=0.83,p=0.01).

Conclusions Oestrogen supplementation may worsen ocular symptoms in postmenopausal women with dry eye, whereas no impact of testosterone therapy on symptoms was apparent. The positive effects of oestrogen and testosterone on tear function require confirmation in a larger study, with sample size calculated from the data generated herein. Placebo control is essential in studies of dry eye therapies.

Trial registration number ACTRN12612000281897.

  • Drugs
  • Tears
  • Ocular surface

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Footnotes

  • Contributors BG, JE and FS: conception and design. BG, JE, FS, NB, JL, LG, JR, JY and UH: data collection, analysis and/or interpretation. BG, FS and JY: drafting the article. All authors: revising it critically for important intellectual content. BG and FS: final approval of the version to be published. All authors read and approved the final manuscript.

  • Funding UNSW Australia Faculty of Science Interdisciplinary Research Grants Program, 2013.

  • Competing interests None declared.

  • Ethics approval UNSW HREC.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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