NCT07151612

The Development of New Functions of Esculin and Digitalis Glycosides Eye Drops: A Study on the Treatment of Presbyopia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Shanxi Eye Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Presbyopia is a condition where the eyes cannot focus a clear image on the retina when looking at nearby objects, commonly seen in people over 40 years old, which has a serious impact on people's daily work and life. However, up to now, there have been no reports in China about the approval of presbyopia treatment drugs for marketing. The theory of presbyopia regulation mechanism suggests that the accommodation of the human eye is closely related to the contraction function of the ciliary muscle. Research has found that the main components of the marketed drug, Ginkgo biloba and Digitalis glycosides eye drops, namely ginkgolide and digitalis glycosides, can act on the ciliary muscle together and effectively enhance the accommodation function of the ciliary muscle. The above results suggest that Ginkgo biloba and Digitalis glycosides eye drops may also treat presbyopia by improving the accommodation function of the ciliary muscle. However, there have been no reports on the therapeutic effect of Ginkgo biloba and Digitalis glycosides eye drops on presbyopia. Therefore, this project will, for the first time, confirm the therapeutic effect of Ginkgo biloba and Digitalis glycosides eye drops on presbyopia based on the changes in visual quality before and after treatment in the experimental group and the control group. Moreover, it will use optometry technology and optical coherence tomography (OCT) and anterior segment blood flow information to examine and analyze the accommodation function and anterior segment OCT and anterior segment blood flow information, etc., to clarify the treatment mechanism. It is hoped that the research of this project can fill the gap in the field of presbyopia drug treatment in China.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	Esculin and Digitalisglycosides Eye Drops	Interventions were performed using esculin and digitalis glycosides eye drops (Pharma Stulln GmbH). The carer instructed the patient to apply 1 drop to the affected eye three times a day and to strictly follow aseptic techniques to prevent contact of the dropper with the ocular surface. The treatment lasted for 1 month.
DRUG	Normal saline solution	Sterile, preservative-free, and non-irritating dropper saline was used. The carer instructed the patient to apply 1 drop to the affected eye three times a day and to strictly follow aseptic techniques to prevent contact of the dropper with the ocular surface.

Timeline

• Start date: 2025-09-04
• Primary completion: 2025-10-08
• Completion: 2025-10-10
• First posted: 2025-09-03
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

1 site across 1 country: China