Trial Outcomes & Findings for Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population (NCT NCT05926258)
NCT ID: NCT05926258
Last Updated: 2026-03-09
Results Overview
Efficacy outcome: assess of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
day 1
Results posted on
2026-03-09
Participant Flow
Participant milestones
| Measure |
Chloroprocaine 3% Gel
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Chloroprocaine 3% eye gel: ocular surface anesthesia
|
Oxybuprocaine 0,4% Solution
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops: ocular surface anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
|
Overall Study
COMPLETED
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
Baseline characteristics by cohort
| Measure |
Chloroprocaine 3% Gel
n=37 Participants
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Chloroprocaine 3% eye gel: ocular surface anesthesia
|
Oxybuprocaine 0,4% Solution
n=36 Participants
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops: ocular surface anesthesia
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
37 Participants
n=68 Participants
|
36 Participants
n=69 Participants
|
73 Participants
n=137 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=68 Participants
|
12 Participants
n=69 Participants
|
26 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=68 Participants
|
24 Participants
n=69 Participants
|
47 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=68 Participants
|
32 Participants
n=69 Participants
|
65 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=137 Participants
|
PRIMARY outcome
Timeframe: day 1Efficacy outcome: assess of patients in each treatment group with a successful conjunctiva anesthesia in the right eye, 5 minutes after study product administration, i.e. right before the ocular examination, to be assessed by eye spear sponge.
Outcome measures
| Measure |
Chloroprocaine 3% Gel
n=37 Participants
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Chloroprocaine 3% eye gel: ocular surface anesthesia
|
Oxybuprocaine 0,4% Solution
n=36 Participants
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops: ocular surface anesthesia
|
|---|---|---|
|
Conjunctiva Anesthesia With Chloroprocaine 3% Eye Gel as Compared With Oxybuprocaine Chlorhydrate 0.4% Eye Drops
|
19 participants
|
23 participants
|
SECONDARY outcome
Timeframe: from day 1 until study end (day 8 or day 15)Evaluation of safety by assessing the occurrence of adverse events throughout the study
Outcome measures
| Measure |
Chloroprocaine 3% Gel
n=37 Participants
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Chloroprocaine 3% eye gel: ocular surface anesthesia
|
Oxybuprocaine 0,4% Solution
n=36 Participants
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops: ocular surface anesthesia
|
|---|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: day 1, post doseEvaluation of safety by assessing the product global tolerance graded by the Investigator by answering the following question "How do you consider the study product global tolerance" using the following scale: 0=very unsatisfactory, 1=unsatisfactory, 2= satisfactory, 3=very satisfactory.
Outcome measures
| Measure |
Chloroprocaine 3% Gel
n=37 Participants
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Chloroprocaine 3% eye gel: ocular surface anesthesia
|
Oxybuprocaine 0,4% Solution
n=36 Participants
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops: ocular surface anesthesia
|
|---|---|---|
|
Assessing the Product Global Tolerance Graded
Scores 3
|
25 Participants
|
27 Participants
|
|
Assessing the Product Global Tolerance Graded
Scores 2
|
10 Participants
|
7 Participants
|
|
Assessing the Product Global Tolerance Graded
Scores 1
|
0 Participants
|
0 Participants
|
|
Assessing the Product Global Tolerance Graded
Score 0
|
1 Participants
|
2 Participants
|
|
Assessing the Product Global Tolerance Graded
Not done
|
1 Participants
|
0 Participants
|
Adverse Events
Chloroprocaine 3% Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Oxybuprocaine 0,4% Solution
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 |
Chloroprocaine 3% Gel
n=37 participants at risk
The assigned investigational product (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Chloroprocaine 3% eye gel: ocular surface anesthesia
|
Oxybuprocaine 0,4% Solution
n=36 participants at risk
The assigned active comparator (2 drops) will be instilled in both eyes of each subject. Administrations will be performed at the clinical centre by the Investigator or his/her deputy on study day 1. For each administration, the 2 drops will be instilled one at the time, at a 1 min interval.
Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops: ocular surface anesthesia
|
|---|---|---|
|
Eye disorders
eye pruritus
|
2.7%
1/37 • Number of events 1 • 18 days
Any untoward medical occurrence that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event that may jeopardize the patient's health status or may require intervention to prevent one of the other outcomes listed in the definition above.
|
0.00%
0/36 • 18 days
Any untoward medical occurrence that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event that may jeopardize the patient's health status or may require intervention to prevent one of the other outcomes listed in the definition above.
|
|
Eye disorders
Injury corneal
|
2.7%
1/37 • Number of events 1 • 18 days
Any untoward medical occurrence that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event that may jeopardize the patient's health status or may require intervention to prevent one of the other outcomes listed in the definition above.
|
0.00%
0/36 • 18 days
Any untoward medical occurrence that at any dose: * results in death * is life-threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event that may jeopardize the patient's health status or may require intervention to prevent one of the other outcomes listed in the definition above.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60