Healthy Volunteers
Conditions
Brief summary
The study assess efficacy, safety and tolerability of Chloroprocaine 3% ophthalmic gel in healthy volunteers.
Detailed description
The study is carried out in 2 parts. In part I, safety and tolerability is assessed in three groups (12 subjects per group) for single and multiple instillations (1 drop, 3 drops and 3+3 drops). In each group, 9 subjects is randomized to receive Chloroprocaine 3% Gel and 3 subjects receive vehicle as control in the right eye. After part I is completed, an internal independent board review safety endpoints of data collected from these first subjects and advise to go on with further enrollment. If no safety concerns arise, in part II efficacy, safety and tolerability is assessed in 60 healthy subjects for the 3 drops dose regimen. 40 subjects receive Chloroprocaine 3% Gel and 20 receive vehicle (2:1 randomization) in the right eye.
Interventions
DRUGOcular gel
Instillation
Sponsors
Sintetica SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed and dated informed consent 2. Healthy male or female aged from 18 to 90 years 3. No clinically significant ocular or systemic disease 4. Ability to orally respond to pain 5. Ability to follow the visit schedule
Exclusion criteria
Ophthalmic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Phase 2 With Anesthesia Success | Day 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Up to 29 days | Number of Participants with Ocular symptoms and Adverse events |
| Mean Arterial Pressure | up to 8 days | Mean 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). |
| Duration of Anesthesia Only in Patients in Phase 2 | Day 1 | Duration of anesthesia (min) for subjects in phase 2 (the intent was to collect and only report data for Participants who were in Phase 2) |
| Number of Participants With Anomalies in Corneal Fluorescein Staining | up to 8 days | Number of Participants with anomalies found with corneal fluorescein staining |
| Ocular Pressure | Follow up (up to 8 days) | Intraocular pressure (mmHg) |
| Number of Participants With Anomalies in Slip Lamp Examination | up to 8 days | Number of Participants with Anomalies in Slip Lamp Examination |
Countries
Austria
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Chloroprocaine Chloroprocaine 3% ocular gel
Ocular gel: Instillation | 67 |
| Placebo Vehicle for chloroprocaine 3% ocular gel
Ocular gel: Instillation | 29 |
| Total | 96 |
Baseline characteristics
| Characteristic | Placebo | Total | Chloroprocaine |
|---|---|---|---|
| Age, Continuous | 25.7 years STANDARD_DEVIATION 5.5 | 25.6 years STANDARD_DEVIATION 5.4 | 25.5 years STANDARD_DEVIATION 5.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 96 Participants | 67 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 52 Participants | 36 Participants |
| Sex: Female, Male Male | 13 Participants | 44 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 29 |
| other Total, other adverse events | 43 / 67 | 15 / 29 |
| serious Total, serious adverse events | 0 / 67 | 0 / 29 |
Outcome results
Primary
Number of Participants in Phase 2 With Anesthesia Success
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)
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chloroprocaine | Number of Participants in Phase 2 With Anesthesia Success | Anesthesia success | 38 participants |
| Chloroprocaine | Number of Participants in Phase 2 With Anesthesia Success | No success | 2 participants |
| Placebo | Number of Participants in Phase 2 With Anesthesia Success | Anesthesia success | 4 participants |
| Placebo | Number of Participants in Phase 2 With Anesthesia Success | No success | 16 participants |
Secondary
Duration of Anesthesia Only in Patients in Phase 2
Duration of anesthesia (min) for subjects in phase 2 (the intent was to collect and only report data for Participants who were in Phase 2)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chloroprocaine | Duration of Anesthesia Only in Patients in Phase 2 | 24.15 minutes | Standard Deviation 8.83 |
| Placebo | Duration of Anesthesia Only in Patients in Phase 2 | 19.3 minutes | Standard Deviation 14.72 |
Secondary
Mean Arterial Pressure
Mean 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).
Time frame: up to 8 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chloroprocaine | Mean Arterial Pressure | Visit 1 Screening | 95 mmHg | Standard Deviation 9 |
| Chloroprocaine | Mean Arterial Pressure | Visit 2 pre-dose | 96 mmHg | Standard Deviation 8 |
| Chloroprocaine | Mean Arterial Pressure | Visit 2 post-dose | 95 mmHg | Standard Deviation 8 |
| Chloroprocaine | Mean Arterial Pressure | Visit 4 Follow-up | 95 mmHg | Standard Deviation 8 |
| Placebo | Mean Arterial Pressure | Visit 4 Follow-up | 94 mmHg | Standard Deviation 9 |
| Placebo | Mean Arterial Pressure | Visit 1 Screening | 94 mmHg | Standard Deviation 9 |
| Placebo | Mean Arterial Pressure | Visit 2 post-dose | 92 mmHg | Standard Deviation 9 |
| Placebo | Mean Arterial Pressure | Visit 2 pre-dose | 94 mmHg | Standard Deviation 9 |
Secondary
Number of Participants With Adverse Events
Number of Participants with Ocular symptoms and Adverse events
Time frame: Up to 29 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chloroprocaine | Number of Participants With Adverse Events | 43 participants |
| Placebo | Number of Participants With Adverse Events | 15 participants |
Secondary
Number of Participants With Anomalies in Corneal Fluorescein Staining
Number of Participants with anomalies found with corneal fluorescein staining
Time frame: up to 8 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chloroprocaine | Number of Participants With Anomalies in Corneal Fluorescein Staining | 0 participants |
| Placebo | Number of Participants With Anomalies in Corneal Fluorescein Staining | 0 participants |
Secondary
Number of Participants With Anomalies in Slip Lamp Examination
Number of Participants with Anomalies in Slip Lamp Examination
Time frame: up to 8 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chloroprocaine | Number of Participants With Anomalies in Slip Lamp Examination | 17 participants |
| Placebo | Number of Participants With Anomalies in Slip Lamp Examination | 5 participants |
Secondary
Ocular Pressure
Intraocular pressure (mmHg)
Time frame: Follow up (up to 8 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chloroprocaine | Ocular Pressure | screening | 14 mmHg | Standard Deviation 2.6 |
| Chloroprocaine | Ocular Pressure | follow up | 13.6 mmHg | Standard Deviation 2.6 |
| Placebo | Ocular Pressure | screening | 14 mmHg | Standard Deviation 2.3 |
| Placebo | Ocular Pressure | follow up | 13.3 mmHg | Standard Deviation 2 |