PresbyopiaPhase 4NCT07151612
The Development of New Functions of Esculin and Digitalis Glycosides Eye Drops: A Study on the Treatment of Presbyopia
A Phase 4 study testing Esculin and Digitalisglycosides Eye Drops and Normal saline solution in people with Presbyopia, run by Shanxi Eye Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- Esculin and Digitalisglycosides Eye Drops and Normal saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 10 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Esculin and Digitalisglycosides Eye Drops, Normal saline solution
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esculin and Digitalisglycosides Eye DropsDrug
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.
Normal saline solutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Esculin and Digitalisglycosides Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1.5 hours post-dose 1 on day 30
Secondary outcomes (2)
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.
Measured: at 0.5 and 3 hours post-dose 1 on day 30
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
Measured: at the three measurement time points on the 30th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start4 Sep 2025
- Primary completion8 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Zhang, Principal investigator, Shanxi Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151612
- Sponsor's protocol ID
- SXYYLL-20240310
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2025
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of New Functions of Esculin and Digitalis Glycosides Eye Drops: A Study on the Treatment of Presbyopia
- ClinicalTrials.gov ID
- NCT07151612
- Acronym / sponsor ID
- SXYYLL-20240310
- Conditions
- Presbyopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shanxi Eye HospitalUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline solution | Placebo comparator | Drug: Normal saline solutionThe 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 | Drug: Esculin and Digitalisglycosides Eye DropsThe 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esculin and Digitalisglycosides Eye DropsInterventions 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 | Esculin and Digitalisglycosides Eye Drops |
| Normal saline solutionSterile, 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. | Drug | Normal saline solution |
Primary outcome
DCNVA
Time frame: at 1.5 hours post-dose 1 on day 30
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.
2 secondary outcomes
DCNVA
Time frame: at 0.5 and 3 hours post-dose 1 on day 30
DCNVA
Time frame: at the three measurement time points on the 30th day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Presbyopia
Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Zhang principal investigator
Shanxi Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esculin and Digitalisglycosides Eye Drops and Normal saline solution in people with Presbyopia, run by Shanxi Eye Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCNVA (time frame: at 1.5 hours post-dose 1 on day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.