CompletedPhase 4

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

China62 participantsStarted 2025-09-04

Plain-language 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.

Who can participate

Age range

40 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age is within the range of 40 - 55 years old. * After mydriasis, for one eye, the refractive power is within -0.5D - 2.0D and the astigmatism is ≤ 1.0D. * When measuring uncorrected visual acuity with a standard logarithmic visual acuity chart, the uncorrected distance visual acuity (UDVA) of both eyes is ≥ 1.25, and the uncorrected near visual acuity (UNVA) is ≤ 0.8. * When using a slit lamp to detect cataract development according to the LOCS Ⅲ grading standard, no NO3 - NC3 or more severe lens opacity is detected; and no ocular surface diseases, visual fatigue, or any corneal diseases (such as dry eye, corneal injury, corneal opacity, keratoconus, or having undergone corneal refractive surgery, etc.) are detected. * The subject has not used Ginkgo biloba extract dichloride eye drops within 2 weeks; has no known or suspected allergy to digitalis - like drugs; and has not used insulin, anti - anxiety drugs, antidepressants, antipsychotics, antihistamines, antispasmodics, diuretics, etc. Exclusion Criteria: * Age is not in the range of 40 - 55 years old. * After mydriasis, for one eye, the refractive power is higher than 2.0D or lower than -0.5D, or the astigmatism is higher than 1.0D. * When measuring the uncorrected distance visual acuity (UDVA) of both eyes with a standard logarithmic visual acuity chart, if the UDVA is lower than 1.25, or the uncorrected near visual acuity (UNVA) is higher than 0.8. * When using a slit lamp to detect cataract deve…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DCNVA

Timeframe: at 1.5 hours post-dose 1 on day 30

Trial details

NCT IDNCT07151612

SponsorShanxi Eye Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-08

Results submitted2025-11-25

View on ClinicalTrials.gov More Presbyopia trials