Women experience dry eye symptoms at a higher incidence than men. Postmenopausal women are a particularly higher risk of developing symptoms. Researchers believe this points to the involvement of hormones in the progression of the disease, and have developed a new topical treatment to help reduce the symptoms of dry eye disease in postmenopausal women.
Estrogen levels drop dramatically, which results in dry eyes. Dry eyes can affect vision and ocular comfort, causing excessive watering, itchiness, and eye strain.
Researchers conducted a randomized, controlled study using the RP101 drops, which contain 17-beta-estradiol as the active ingredient in a thermo-sensitive hydrogel that becomes a gel at eye temperature. This allows the drops to remain on the ocular surface for a longer time period thus allowing the drug to be delivered over a longer period of time.
Of the 104 women enrolled, 77 postmenopausal women who suffered with moderate-to-severe dry eye disease completed the study. The treatment period lasted for three months, with participants receiving the drops twice daily.
Researchers used Schirmer II Tests (a paper strip measurement of their tear production) on days 14, 30, 60 and 90. The results showed an increase in tear production with the greatest effect after 90 days of treatment.
Patients also completed a Symptom Assessment Questionnaire in Dry Eye (SANDE) and the visual analog scales (VAS). Patients indicated a decrease in symptoms of dry eye at the end of the 90-day treatment period.
In addition, the drops were well-tolerated on the surface of the eye and were found to be safe.