Anesthesia, Local
Conditions
Keywords
AG-920, Articaine, Septocaine, Intravitreal Injection, Proparacaine
Brief summary
A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.
Detailed description
A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 compared to Proparacaine. In this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). Subjects who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG 920 or Proparacaine into one (study) eye. Each dose of AG-920 or Proparacaine HCl will consist of two drops in the study eye. After the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.
Interventions
DRUGAG-920
AG-920 Sterile Topical Ophthalmic Solution
0.5% Proparacaine Hydrochloride
Sponsors
American Genomics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
The study is single masked. Treatment assignments will be masked to the subjects and their parent/legal guardian only.
Intervention model description
Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or proparacaine into one (study) eye (2 drops 30 seconds apart).
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pre-pubescent with no childbearing potential 2. Capable of undergoing an eye exam 3. Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed. 4. Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study. 5. Have a healthy, normal cornea.
Exclusion criteria
1. Have participated in an investigational study (drug or device) within the past 30 days. 2. Have a known contraindication to local anesthetics. 3. Children with known autism spectrum disorders or known to have heightened sensitivity. 4. Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret. 5. Have low visual acuity 6. Manifest nystagmus 7. Have had ocular surgery or general surgery within the past 45 days. 8. Have had an intravitreal injection in either eye within 14 days of randomization. 9. Have ocular surface disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants in Which an Eye Exam Was Able to be Performed | Two to four minutes following treatment (last drop) of IMP | Was the investigator was able to perform the eye examination without additional anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From randomization through study completion (up to 4 days following treatment) | TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC. Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs). |
Countries
United States
Participant flow
Recruitment details
Sixty (60) pediatric subjects were randomized and treated in a phase 1 unit between 6 April 2022 to 27 May 2022.
Participants by arm
| Arm | Count |
|---|---|
| AG-920 Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.
AG-920: AG-920 Sterile Topical Ophthalmic Solution | 30 |
| Proparacaine 0.5% Proparacaine Hydrochloride
Proparacaine Ophthalmic: 0.5% Proparacaine Hydrochloride | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Proparacaine | AG-920 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.3 years STANDARD_DEVIATION 2.5 | 5.2 years STANDARD_DEVIATION 3.1 | 5.8 years STANDARD_DEVIATION 2.9 |
| Color of Iris Brown | 28 Participants | 30 Participants | 58 Participants |
| Color of Iris Green | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 30 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 1 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 30 Participants | 59 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
| Study Eye Left Eye | 15 Participants | 15 Participants | 30 Participants |
| Study Eye Right Eye | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
The Proportion of Participants in Which an Eye Exam Was Able to be Performed
Was the investigator was able to perform the eye examination without additional anesthesia
Time frame: Two to four minutes following treatment (last drop) of IMP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AG-920 | The Proportion of Participants in Which an Eye Exam Was Able to be Performed | 30 Participants |
| Proparacaine | The Proportion of Participants in Which an Eye Exam Was Able to be Performed | 30 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC. Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).
Time frame: From randomization through study completion (up to 4 days following treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AG-920 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0 Participants |
| Proparacaine | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 0 Participants |