Trial Outcomes & Findings for A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution (NCT NCT04829344)
NCT ID: NCT04829344
Last Updated: 2024-10-10
Results Overview
Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
5 minutes post dose
Results posted on
2024-10-10
Participant Flow
One hundred and twenty one (121) subjects were screened, of which 120 were randomized and treated, all of whom completed the study. First subject screened 30March2021, last subject completed 10May2021.
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%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Baseline characteristics by cohort
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
34.9 year
STANDARD_DEVIATION 15.6 • n=5 Participants
|
37.0 year
STANDARD_DEVIATION 14.4 • n=7 Participants
|
35.9 year
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
BCVA LogMar Study Eye
|
0.0 LogMar
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
BCVA LogMar Fellow Eye
|
0.0 LogMar
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Color of Iris
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Color of Iris
Brown
|
56 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Color of Iris
Green
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Color of Iris
Hazel
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
IOP Study Eye
|
14.6 mmHg
STANDARD_DEVIATION 2.7 • n=5 Participants
|
14.5 mmHg
STANDARD_DEVIATION 2.6 • n=7 Participants
|
14.5 mmHg
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
IOP Fellow Eye
|
14.7 mmHg
STANDARD_DEVIATION 2.7 • n=5 Participants
|
14.5 mmHg
STANDARD_DEVIATION 2.7 • n=7 Participants
|
14.6 mmHg
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutes post doseImmediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
Anesthetic Response (painless)
|
50 Participants
|
11 Participants
|
|
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
No Anesthetic Response (pain)
|
10 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.Mean time to no pain score (onset)
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
How Long it Takes One Dose of AG-920 to Anesthetize the Eye
|
0.43 minutes
Standard Deviation 0.61
|
1.0 minutes
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.Mean duration of anesthetic effect
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
How Long One Dose of AG-920 Anesthetizes the Eye
|
12.78 minutes
Standard Deviation 7.97
|
6.61 minutes
Standard Deviation 10.21
|
SECONDARY outcome
Timeframe: from randomization through study completion (up to 5 days) on average of 2 days.Total number of participants with TEAEs
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: change from baseline through end of study at Day 5Population: Slit Lamp Examination Assessment change from baseline
Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured timepoint using discrete summary statistics. Clinician examined the eyelid, conjunctiva, cornea, anterior chamber, iris, pupil, and lens of the eye with the aid of a slit lamp.
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Participants With a Change in Biomicroscopy
Study Eye
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change in Biomicroscopy
Fellow Eye
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: change from baseline through end of study at Day 5Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR).
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 Participants
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Change in Visual Acuity
Study Eye
|
-0.03 LogMAR
Standard Deviation 0.12
|
-0.02 LogMAR
Standard Deviation 0.06
|
|
Change in Visual Acuity
Fellow Eye
|
-0.01 LogMAR
Standard Deviation 0.05
|
-0.02 LogMAR
Standard Deviation 0.07
|
Adverse Events
AG-920
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AG-920
n=60 participants at risk
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=60 participants at risk
Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.
Placebo: Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Eye disorders
conjunctival hyperemia
|
11.7%
7/60 • Number of events 7 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed. This is a maximum of 6 days but an average of 2 days. If a subject had an ongoing AE at the time of study completion, the event was to be followed-up according to the site's standard of care and the subject provided appropriate medical care until the event resolved or stabilized.
|
3.3%
2/60 • Number of events 2 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed. This is a maximum of 6 days but an average of 2 days. If a subject had an ongoing AE at the time of study completion, the event was to be followed-up according to the site's standard of care and the subject provided appropriate medical care until the event resolved or stabilized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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