Treatment of menopausal keratoconjunctivitis sicca with topical oestradiol

OBJECTIVE: To investigate the effect of 17 beta-oestradiol ophthalmic drops in comparison with a traditional tear substitute in postmenopausal women with keratoconjunctivitis sicca. DESIGN: Randomised prospective trial. SETTING: Menopause clinic. PARTICIPANTS: Eighty-four postmenopausal women suffering from keratoconjunctivitis sicca and necessitating a hormone replacement therapy (HRT) for general climacteric symptoms. METHODS: The women were randomised into two groups and were given 17 beta-oestradiol eye drops (n = 42, group 1) or a tear substitute (n = 42, group 2). Both groups received a systemic HRT. MAIN OUTCOME MEASURES: A Schirmer's test was performed immediately before the beginning of therapy and after four months. In addition, eye symptoms were assessed using a visual analogue scale. RESULTS: A comparison of visual analogue scores at four months in the women who received 17 beta-oestradiol eye drops versus those who received a tear substitute demonstrated a statistically significant difference in all observed ocular symptoms (P < 0.0001). The Schirmer's test revealed a significant difference of results before and after treatment in the oestradiol group (P < 0.0001) while in group 2 no significant difference was found. CONCLUSIONS: Our study demonstrates that topical oestrogen is successful in treating keratoconjunctivitis sicca while it seems that the blood-eye barrier prevents systemic oestrogens from acting on the conjunctivae.