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

NCT07151612 | Completed Phase 4 Results

• 1 other identifier: SXYYLL-20240310
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• DCNVA

  The proportion of participants gaining ≥3 lines from baseline in DCNVA without losing more than one line of CDVA under both photopic and mesopic conditions at 1.5 hours post-dose 1 on day 30.

  at 1.5 hours post-dose 1 on day 30

Secondary Outcomes (2)

• DCNVA

  at 0.5 and 3 hours post-dose 1 on day 30

• DCNVA

  at the three measurement time points on the 30th day

Study Arms (2)

Normal saline solution

PLACEBO COMPARATOR

The control group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding.

Drug: Normal saline solution

Esculin and Digitalisglycosides Eye Drops

EXPERIMENTAL

The treatment group received esculin and digitalis glycosides eye drops (Pharma Stulln GmbH). Patients were instructed to instill one drop in the affected eye three times daily, with strict adherence to aseptic techniques to prevent dropper-to-ocular surface contact.

Drug: Esculin and Digitalisglycosides Eye Drops

Interventions

Esculin and Digitalisglycosides Eye Drops DRUG

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.

Esculin and Digitalisglycosides Eye Drops

Normal saline solution DRUG

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.

Normal saline solution

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 development according to the LOCS Ⅲ grading standard, NO3 - NC3 or more severe lens opacity is detected in the lens; or 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 used Ginkgo biloba extract dichloride eye drops within 2 weeks; has known or suspected allergy to digitalis - like drugs; or has used insulin, anti - anxiety drugs, antidepressants, antipsychotics, antihistamines, antispasmodics, diuretics, etc.

Sponsors & Collaborators

• Shanxi Eye Hospital: lead

Study Sites (1)

Shanxi Eye Hospital

Taiyuan, Shanxi, 030000, China

Location

MeSH Terms

Conditions

Presbyopia

Interventions

Esculin; Saline Solution

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glucosides; Glycosides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: YuZhang
• Organization: Shanxi Eye Hospital

zy15525463968@163.com

0351-8286884

Study Officials

• Yu Zhang

  Shanxi Eye Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: September 3, 2025
• Study Start: September 4, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 10, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)