Efficacy of Artificial Tears Containing Trehalose and Hyaluronic Acid (Thealoz Duo^®) for Dry Eye Disease (DED in Peri- and Postmenopausal Women

Abstract

Purpose : Postmenopausal women have a high incidence of DED, probably due to sex hormone imbalances. This study evaluated efficacy of a 3-month daily treatment with artificial tears containing trehalose and hyaluronic acid in peri- and postmenopausal women with moderate and severe DED

Methods : This was a post hoc analysis of peri- and postmenopausal women (ages 42-54 and ≥55 years, respectively) with an Ocular Surface Disease Index (OSDI) ≥18 who had participated in a Phase III (NCT02023268) and a Phase IV (NCT02617095) studies assessing the efficacy of artificial tears containing trehalose (30 mg/mL) and hyaluronic acid (1.5 mg/mL) on the signs and symptoms of DED Patients instilled one drop of the artificial tears in each eye 3 to 6 times daily and were evaluated at baseline and after 84±7 days for DED symptom severity (measured with the OSDI), visual acuity (Snellen optotype), hyperemia (MacMonnies scale), tear break-up time (TBUT, fluorescein), corneal and conjunctival staining (Oxford and Van Bjisterveld scales), tear production (Schirmer’s test), and symptoms (visual analogue scale).

Results : A total of 59 women were analyzed (16 perimenopausal; 43 postmenopausal, mean±SD age=48.6±4.2 and 66.9±8.0 years, respectively). After 84 days of treatment, the OSDI (mean±SD) decreased from 59.2±24.7 to 22.9±17.3 in perimenopausal and from 52.6±20.7 to 29.1±24.3 in postmenopausal women (both p<0.0001). Visual acuity remained unchanged in both groups. Conjunctival hyperemia, TBUT, and corneal and conjunctival staining with fluorescein or lissamine green improved significantly in both groups (all p<0.0001). Tear production also increased in peri- (p=0.0101) and postmenstrual women (p=0.0005). Conjunctival hyperemia, TBUT, and corneal and conjunctival staining (Oxford scale) improved more significantly in peri- than postmenopausal women. Severe symptoms at baseline and absence of symptoms at day 84 were also reported more frequently by peri- than postmenopausal women.

Conclusions : Signs and symptoms of DED improved significantly in peri- and postmenopausal women treated for 3 months with artificial tears containing trehalose and hyaluronic acid, suggesting that it is an effective treatment for eye dryness in this population. Improvement was often significantly greater in peri- than in postmenopausal women.

This is a 2021 ARVO Annual Meeting abstract.