The effects of transdermal testosterone and oestrogen therapy on dry eye in postmenopausal women: a randomised, placebo-controlled, pilot study.
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.



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.



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).



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.



ACTRN12612000281897.
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.
Blanka
B
Golebiowski
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.
Noor
N
Badarudin
Sydney Menopause Centre, Royal Hospital for Women, Randwick, New South Wales, Australia.|School of Women's and Children's Health, UNSW Australia, Sydney, New South Wales, Australia.
John
J
Eden
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.
Leanne
L
Gerrand
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.
Jennifer
J
Robinson
Sydney Menopause Centre, Royal Hospital for Women, Randwick, New South Wales, Australia.
Jinzhu
J
Liu
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.|Department of Ophthalmology, University Medical Center of the Johannes Gutenberg-University Mainz, Germany.
Ulrike
U
Hampel
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.|Save Sight Institute, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
Jingjing
J
You
School of Optometry and Vision Science, UNSW Australia, Sydney, New South Wales, Australia.
Fiona
F
Stapleton
D000279:Administration, Cutaneous; D000728:Androgens / Q000008:administration & dosage; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000378:metabolism; D004967:Estrogens / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008537:Meibomian Glands / Q000187:drug effects / Q000378:metabolism*; D008875:Middle Aged; D010865:Pilot Projects; D017698:Postmenopause; D012189:Retrospective Studies; D013666:Tears / Q000378:metabolism*; D013739:Testosterone / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
D000728:Androgens; D004967:Estrogens; D013739:Testosterone
Drugs; Ocular surface; Tears