Trial Outcomes & Findings for The Development of New Functions of Esculin and Digitalis Glycosides Eye Drops: A Study on the Treatment of Presbyopia (NCT NCT07151612)
NCT ID: NCT07151612
Last Updated: 2026-03-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
at 1.5 hours post-dose 1 on day 30
Results posted on
2026-03-25
Participant Flow
Unit of analysis: Study Eyes
Participant milestones
| Measure |
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.
|
The Vehicle Group
The vehicle group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding.
|
|---|---|---|
|
Overall Study
STARTED
|
31 31
|
31 31
|
|
Overall Study
COMPLETED
|
31 31
|
31 31
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
the Treatment Group
n=31 Study Eyes
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.
|
The Vehicle Group
n=31 Study Eyes
The vehicle group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding.
|
Total
n=62 Study Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=31 Participants
|
31 Participants
n=31 Participants
|
62 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=31 Participants
|
18 Participants
n=31 Participants
|
39 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=31 Participants
|
13 Participants
n=31 Participants
|
23 Participants
n=62 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
62 participants
n=62 Participants
|
|
Distance-corrected near visual acuity (DCNVA)
|
0.45 logMAR
STANDARD_DEVIATION 0.14 • n=31 Study Eyes • 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.
|
0.42 logMAR
STANDARD_DEVIATION 0.10 • n=31 Study Eyes • 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.
|
0.43 logMAR
STANDARD_DEVIATION 0.12 • n=62 Study Eyes • 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.
|
|
corrected-distance visual acuity (CDVA)
|
0.02 logMAR
STANDARD_DEVIATION 0.00 • n=31 Study Eyes
|
0.03 logMAR
STANDARD_DEVIATION 0.18 • n=31 Study Eyes
|
0.02 logMAR
STANDARD_DEVIATION 0.13 • n=62 Study Eyes
|
|
DCIVA
|
0.16 logMAR
STANDARD_DEVIATION 0.10 • n=31 Study Eyes
|
0.15 logMAR
STANDARD_DEVIATION 0.09 • n=31 Study Eyes
|
0.16 logMAR
STANDARD_DEVIATION 0.10 • n=62 Study Eyes
|
|
pupil diameter (PD)
|
3.44 mm
STANDARD_DEVIATION 0.27 • n=31 Study Eyes
|
3.42 mm
STANDARD_DEVIATION 0.49 • n=31 Study Eyes
|
3.43 mm
STANDARD_DEVIATION 0.50 • n=62 Study Eyes
|
|
amplitude of accommodation (AMP)
|
3.50 diopter
STANDARD_DEVIATION 0.42 • n=31 Study Eyes
|
3.51 diopter
STANDARD_DEVIATION 0.49 • n=31 Study Eyes
|
3.50 diopter
STANDARD_DEVIATION 0.46 • n=62 Study Eyes
|
PRIMARY outcome
Timeframe: at 1.5 hours post-dose 1 on day 30Population: 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.
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.
Outcome measures
| Measure |
the Treatment Group
n=31 Participants
The treatment group received esculin and digitalis glycosides eye drops. 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.
|
The Control Group
n=31 Participants
The control group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding.
|
|---|---|---|
|
DCNVA
|
8 Participants
0.01
|
1 Participants
0.01
|
SECONDARY outcome
Timeframe: at 0.5 and 3 hours post-dose 1 on day 30The 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.
Outcome measures
| Measure |
the Treatment Group
n=31 Participants
The treatment group received esculin and digitalis glycosides eye drops. 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.
|
The Control Group
n=31 Participants
The control group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding.
|
|---|---|---|
|
DCNVA
3 hours post-dose 1 on day 30
|
8 Participants
|
2 Participants
|
|
DCNVA
0.5 hours post-dose 1 on day 30
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: at the three measurement time points on the 30th dayOther 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
Outcome measures
| Measure |
the Treatment Group
n=31 Participants
The treatment group received esculin and digitalis glycosides eye drops. 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.
|
The Control Group
n=31 Participants
The control group received an equivalent volume of sterile, preservative-free, nonirritating saline packaged in identical containers to maintain blinding.
|
|---|---|---|
|
DCNVA
0.5 hours post-dose 1 on day 30
|
10 Participants
|
3 Participants
|
|
DCNVA
1.5 hours post-dose 1 on day 30
|
11 Participants
|
3 Participants
|
|
DCNVA
3 hours post-dose 1 on day 30
|
10 Participants
|
3 Participants
|
Adverse Events
Normal Saline Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Esculin and Digitalisglycosides Eye Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Saline Solution
n=4 participants at risk；n=31 participants at risk
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.
|
Esculin and Digitalisglycosides Eye Drops
n=3 participants at risk；n=31 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Eye pain
|
0.00%
0/2 • 30 days
|
0.00%
0/1 • 30 days
|
|
Eye disorders
Eye itching
|
0.00%
0/2 • 30 days
|
0.00%
0/2 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place