Trial Outcomes & Findings for A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population (NCT NCT05325853)
NCT ID: NCT05325853
Last Updated: 2023-10-25
Results Overview
Was the investigator was able to perform the eye examination without additional anesthesia
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
Two to four minutes following treatment (last drop) of IMP
Results posted on
2023-10-25
Participant Flow
Sixty (60) pediatric subjects were randomized and treated in a phase 1 unit between 6 April 2022 to 27 May 2022.
Participant milestones
| Measure |
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
|
Proparacaine
0.5% Proparacaine Hydrochloride
Proparacaine Ophthalmic: 0.5% Proparacaine Hydrochloride
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Baseline characteristics by cohort
| Measure |
AG-920
n=30 Participants
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
|
Proparacaine
n=30 Participants
0.5% Proparacaine Hydrochloride
Proparacaine Ophthalmic: 0.5% Proparacaine Hydrochloride
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
5.2 years
STANDARD_DEVIATION 3.1 • n=99 Participants
|
6.3 years
STANDARD_DEVIATION 2.5 • n=107 Participants
|
5.8 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Study Eye
Left Eye
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Study Eye
Right Eye
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Color of Iris
Brown
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Color of Iris
Green
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Two to four minutes following treatment (last drop) of IMPWas the investigator was able to perform the eye examination without additional anesthesia
Outcome measures
| Measure |
AG-920
n=30 Participants
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
|
Proparacaine
n=30 Participants
0.5% Proparacaine Hydrochloride
Proparacaine Ophthalmic: 0.5% Proparacaine Hydrochloride
|
|---|---|---|
|
The Proportion of Participants in Which an Eye Exam Was Able to be Performed
|
30 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
AG-920
n=30 Participants
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
|
Proparacaine
n=30 Participants
0.5% Proparacaine Hydrochloride
Proparacaine Ophthalmic: 0.5% Proparacaine Hydrochloride
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
AG-920
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proparacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Language in clinical trial agreement states: INVESTIGATIVE SITE, the Principal Investigator, and any other investigators understand and agree that the Study is a multi-center clinical study and that a multi- center publication may be prepared and published by the Sponsor. The INVESTIGATIVE SITE and its investigators will not, individually or together, present or publish any findings, data or results of the Study.
- Publication restrictions are in place
Restriction type: OTHER