Trial Outcomes & Findings for Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers (NCT NCT04753710)
NCT ID: NCT04753710
Last Updated: 2022-03-17
Results Overview
Estimate the proportion of subjects experiencing full anaesthesia of the ocular surface 5 minutes after administration of Chloroprocaine 3% ophthalmic gel (the intent was to collect and only report data for Participants who were in Phase 2)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
96 participants
Primary outcome timeframe
Day 1
Results posted on
2022-03-17
Participant Flow
In part 1: 36 subjects received treatment and completed the study. in part 2: 60 were randomized, 40 in the CHL 3% gel and 20 in the vehicle group.
Participant milestones
| Measure |
Chloroprocaine
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Overall
STARTED
|
67
|
29
|
|
Overall
COMPLETED
|
67
|
29
|
|
Overall
NOT COMPLETED
|
0
|
0
|
|
First Phase
STARTED
|
27
|
9
|
|
First Phase
COMPLETED
|
27
|
9
|
|
First Phase
NOT COMPLETED
|
0
|
0
|
|
Second Phase
STARTED
|
40
|
20
|
|
Second Phase
COMPLETED
|
40
|
20
|
|
Second Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Chloroprocaine
n=67 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.5 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
25.7 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
25.6 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Estimate the proportion of subjects experiencing full anaesthesia of the ocular surface 5 minutes after administration of Chloroprocaine 3% ophthalmic gel (the intent was to collect and only report data for Participants who were in Phase 2)
Outcome measures
| Measure |
Chloroprocaine
n=40 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=20 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Number of Participants in Phase 2 With Anesthesia Success
Anesthesia success
|
38 participants
|
4 participants
|
|
Number of Participants in Phase 2 With Anesthesia Success
No success
|
2 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Day 1Duration of anesthesia (min) for subjects in phase 2 (the intent was to collect and only report data for Participants who were in Phase 2)
Outcome measures
| Measure |
Chloroprocaine
n=40 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=20 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Duration of Anesthesia Only in Patients in Phase 2
|
24.15 minutes
Standard Deviation 8.83
|
19.3 minutes
Standard Deviation 14.72
|
SECONDARY outcome
Timeframe: Up to 29 daysNumber of Participants with Ocular symptoms and Adverse events
Outcome measures
| Measure |
Chloroprocaine
n=67 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Number of Participants With Adverse Events
|
43 participants
|
15 participants
|
SECONDARY outcome
Timeframe: up to 8 daysMean arterial pressure (mmHg) is defined as the average pressure in a patient's arteries during one cardiac cycle. It is considered a better indicator of perfusion to vital organs than systolic blood pressure (SBP).
Outcome measures
| Measure |
Chloroprocaine
n=67 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Mean Arterial Pressure
Visit 1 Screening
|
95 mmHg
Standard Deviation 9
|
94 mmHg
Standard Deviation 9
|
|
Mean Arterial Pressure
Visit 2 pre-dose
|
96 mmHg
Standard Deviation 8
|
94 mmHg
Standard Deviation 9
|
|
Mean Arterial Pressure
Visit 2 post-dose
|
95 mmHg
Standard Deviation 8
|
92 mmHg
Standard Deviation 9
|
|
Mean Arterial Pressure
Visit 4 Follow-up
|
95 mmHg
Standard Deviation 8
|
94 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: up to 8 daysNumber of Participants with Anomalies in Slip Lamp Examination
Outcome measures
| Measure |
Chloroprocaine
n=67 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Number of Participants With Anomalies in Slip Lamp Examination
|
17 participants
|
5 participants
|
SECONDARY outcome
Timeframe: up to 8 daysNumber of Participants with anomalies found with corneal fluorescein staining
Outcome measures
| Measure |
Chloroprocaine
n=67 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Number of Participants With Anomalies in Corneal Fluorescein Staining
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Follow up (up to 8 days)Intraocular pressure (mmHg)
Outcome measures
| Measure |
Chloroprocaine
n=67 Participants
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 Participants
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Ocular Pressure
screening
|
14 mmHg
Standard Deviation 2.6
|
14 mmHg
Standard Deviation 2.3
|
|
Ocular Pressure
follow up
|
13.6 mmHg
Standard Deviation 2.6
|
13.3 mmHg
Standard Deviation 2
|
Adverse Events
Chloroprocaine
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chloroprocaine
n=67 participants at risk
Chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
Placebo
n=29 participants at risk
Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation
|
|---|---|---|
|
Reproductive system and breast disorders
Dysmenorrhea
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Skin and subcutaneous tissue disorders
pruritus
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Cardiac disorders
bradycardia
|
7.5%
5/67 • Number of events 5 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Eye disorders
Conjunctival hemorrhage
|
0.00%
0/67 • Study duration (Up to 29 days)
|
6.9%
2/29 • Number of events 2 • Study duration (Up to 29 days)
|
|
Eye disorders
Conjunctival edema
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Eye disorders
dry eye
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Eye disorders
eye irritation
|
10.4%
7/67 • Number of events 7 • Study duration (Up to 29 days)
|
6.9%
2/29 • Number of events 2 • Study duration (Up to 29 days)
|
|
Eye disorders
mydriasis
|
34.3%
23/67 • Number of events 23 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Eye disorders
ocular hyperemia
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Eye disorders
vision blurred
|
4.5%
3/67 • Number of events 3 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/67 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/67 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
General disorders
fatigue
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
General disorders
instillation site pain
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
General disorders
pain
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
General disorders
Sensation of foreign body
|
4.5%
3/67 • Number of events 3 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Infections and infestations
Covid-19
|
0.00%
0/67 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
2/67 • Number of events 2 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Infections and infestations
Rhinitis
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Infections and infestations
tonsillitis
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Injury, poisoning and procedural complications
ligament sprain
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Investigations
Intraocular pressure increased
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/67 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Nervous system disorders
Headache
|
4.5%
3/67 • Number of events 3 • Study duration (Up to 29 days)
|
13.8%
4/29 • Number of events 4 • Study duration (Up to 29 days)
|
|
Nervous system disorders
presyncope
|
0.00%
0/67 • Study duration (Up to 29 days)
|
3.4%
1/29 • Number of events 1 • Study duration (Up to 29 days)
|
|
Nervous system disorders
syncope
|
1.5%
1/67 • Number of events 1 • Study duration (Up to 29 days)
|
0.00%
0/29 • Study duration (Up to 29 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place