June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Effect of topical oestradiol eye drops on signs and symptoms of dry eye disease in post-menopausal women
Author Affiliations & Notes
  • Gerhard Garhofer
    Medizinische Universitat Wien, Wien, Wien, Austria
  • Leopold Schmetterer
    Medizinische Universitat Wien, Wien, Wien, Austria
    Singapore Eye Research Institute, Singapore, Singapore
  • Martin Vidaeus
    Redwood Pharma AB, Sweden
  • Hans Ageland
    Redwood Pharma AB, Sweden
  • Doreen Schmidl
    Medizinische Universitat Wien, Wien, Wien, Austria
  • Footnotes
    Commercial Relationships   Gerhard Garhofer, Redwood Pharma AB (C); Leopold Schmetterer, Redwood Pharma AB (C); Martin Vidaeus, Redwood Pharma AB (E); Hans Ageland, Redwood Pharma AB (E); Doreen Schmidl, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 1235. doi:
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      Gerhard Garhofer, Leopold Schmetterer, Martin Vidaeus, Hans Ageland, Doreen Schmidl; Effect of topical oestradiol eye drops on signs and symptoms of dry eye disease in post-menopausal women. Invest. Ophthalmol. Vis. Sci. 2021;62(8):1235.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Previous evidence indicates that topical oestradiol may be beneficial for patients with dry eye disease (DED), especially in post-menopausal women. The current phase II study was performed to investigate the effect of a recently developed formulation of oestradiol eye drops on signs and symptoms of DED.

Methods : In this randomized, controlled, parallel-group study, 104 post-menopausal women with moderate to severe dry eye were included. 17-β-oestradiol-3-phosphate eye drops (RP101) were administered in three different dosage groups (group 1: 0.5% twice daily, group 2: 0.1% morning and vehicle in the evening, group 3: 0.1% twice daily) and compared to control (group 4: vehicle IntelliGel, twice daily). Treatment was administered for a total period of three months. Schirmer’s test II, corneal staining and SANDE symptom score were assessed at baseline and at day 14, 30, 60 and 90 after treatment start. Safety was determined via frequency of adverse events.

Results : Schirmer’s test II wetting distance significantly increased in all 4 groups from baseline to day 90 without significant difference between groups (group 1: +5.6±6.7; group 2: +3.7±4.2; group 3: +4.8±4.5, group 4: +4.0±5.3 mm/5min). Statistical significance versus baseline occurred earlier in the treatment groups versus the control group. Corneal staining score was significantly reduced after the three-month treatment period with no significant difference between treatment groups (p<0.001 vs baseline in all groups). Staining of the inferior cornea, however, showed a significantly more pronounced decrease in the highest dose group compared to vehicle (p=0.0463). Symptoms as assessed with the SANDE test decreased at the end of the treatment period in all 4 groups (between -18.7±23.5 and -26.3±28.0 mm for frequency of symptoms and between -13.1±26.8 and -24.1±40.2 mm for severity of symptoms). Topical RP101 eye drops were well tolerated on the ocular surface and showed a favorable safety profile.

Conclusions : The results of the study indicate that topical RP101 eye drops improve signs and symptoms of DED in post-menopausal women. The results of the study showed a good safety profile of the topical ophthalmic formulation. Further adequately powered phase III studies are required to assess therapeutic efficacy of topical oestradiol in the treatment of DED.

This is a 2021 ARVO Annual Meeting abstract.

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