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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 0.5 and 3 hours post-dose 1 on day 30. | at 0.5 and 3 hours post-dose 1 on day 30 |
| DCNVA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Zhang | Shanxi Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Eye Hospital | Taiyuan | Shanxi | 030000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41870663 | Derived | Zhang Y, Wang J, Hao M, Wang C, Zhang X. Safety and efficacy of Esculin and Digitalis glycosides eye drops in individuals with presbyopia. Graefes Arch Clin Exp Ophthalmol. 2026 Mar 23. doi: 10.1007/s00417-026-07184-6. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | the Treatment Group | The investigational product (Esculin and Digitalis glycosides Eye Drops) contains Esculin (0.04 mg/0.4 mL) and Digitalis glycoside (0.006 mg/0.4 mL). The solutions are isotonic and physiologically compatible. |
| FG001 | The Vehicle Group | The vehicle group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population includes all randomized participants who received at least one dose of the study eye drops. For ocular-specific measures, the analysis was performed using the pre-specified study eye (right eye) for each participant.
| ID | Title | Description |
|---|---|---|
| BG000 | the Treatment Group | The investigational product (Esculin and Digitalis glycosides Eye Drops) contains Esculin (0.04 mg/0.4 mL) and Digitalis glycoside (0.006 mg/0.4 mL). The solutions are isotonic and physiologically compatible. |
| BG001 | The Vehicle Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants were required to meet all inclusion criteria in both eyes, and accordingly, both eyes received the allocated intervention. The right eye was then pre-specified as the study eye for the primary efficacy analysis. | Posted | Count of Participants | Participants | at 1.5 hours post-dose 1 on day 30 |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline Solution | The control group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YuZhang | Shanxi Eye Hospital | 0351-8286884 | zy15525463968@163.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2024 | Dec 16, 2025 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2024 | Aug 11, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004929 | Esculin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| 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. |
|
Other efficacy endpoints, defined by the same criteria, included the proportion of participants with ≥2 lines from baseline in DCNVA without losing more than one line of CDVA |
| at the three measurement time points on the 30th day |
The vehicle group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding. |
| BG002 | Total | Total of all reporting groups |
| Study Eyes |
|
| Participants |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Distance-corrected near visual acuity (DCNVA) | Participants were required to meet all inclusion criteria in both eyes, and accordingly, both eyes received the allocated intervention. The right eye was then pre-specified as the study eye for the primary efficacy analysis. | Mean | Standard Deviation | logMAR | Study Eyes |
|
|
| corrected-distance visual acuity (CDVA) | Mean | Standard Deviation | logMAR | Study Eyes |
|
|
| DCIVA | Mean | Standard Deviation | logMAR | Study Eyes |
|
|
| pupil diameter (PD) | Mean | Standard Deviation | mm | Study Eyes |
|
|
| amplitude of accommodation (AMP) | Mean | Standard Deviation | diopter | Study Eyes |
|
|
| OG001 |
| The Control Group |
The control group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding. |
|
|
| Secondary | 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 0.5 and 3 hours post-dose 1 on day 30. | Posted | Oct 2025 | Count of Participants | Participants | at 0.5 and 3 hours post-dose 1 on day 30 |
|
|
|
| Secondary | DCNVA | Other efficacy endpoints, defined by the same criteria, included the proportion of participants with ≥2 lines from baseline in DCNVA without losing more than one line of CDVA | Posted | Oct 2025 | Count of Participants | Participants | at the three measurement time points on the 30th day |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 4 |
| EG001 | Esculin and Digitalisglycosides Eye Drops | 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. 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. | 0 | 31 | 0 | 31 | 0 | 3 |
| Eye itching | Eye disorders | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 3 hours post-dose 1 on day 30 |
|