Trial Outcomes & Findings for A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution (NCT NCT04513652)
NCT ID: NCT04513652
Last Updated: 2022-09-28
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
2022-09-28
Participant Flow
One hundred and twenty (120) subjects were screened, randomized and treated, all of whom completed the study. No subjects failed to meet inclusion/exclusion criteria and no one was discontinued.
Participant milestones
| Measure |
AG-920
Articaine Sterile Topical Ophthalmic Solution (AG-920)
|
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
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 13.72 • n=5 Participants
|
30.02 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
31.31 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutes post dosePopulation: Summary of Proportion of Subjects with No Pain at 5 Minutes
Immediately 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)
|
Placebo
n=60 Participants
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
The Number of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
|
41 Participants
|
2 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.Population: Summary of Time to No Pain (Onset of Anesthesia Effect in Minutes)
Mean time to no pain score (onset)
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920)
|
Placebo
n=60 Participants
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Time in Minutes of AG-920 to Anesthetize the Eye
|
0.442 minutes
Standard Deviation 0.6072
|
0.330 minutes
Standard Deviation 0.0000
|
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.Population: Summary of Pinch Test for Duration (in Minutes) of Anesthetic effect
Mean duration of anesthetic effect
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920)
|
Placebo
n=60 Participants
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
To Evaluate How Long One Dose of AG-920 Anesthetizes the Eye
|
4.833 minutes
Standard Deviation 3.8158
|
0.267 minutes
Standard Deviation 1.4325
|
SECONDARY outcome
Timeframe: from randomization through study completion (up to 4 days following treatment)Population: Summary of Treatment Emergent Adverse Events
TEAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC). Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920)
|
Placebo
n=60 Participants
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All TEAEs
|
34 participants
|
13 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Ocular TEAEs
|
32 participants
|
13 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Non-ocular TEAEs
|
4 participants
|
0 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 time point 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)
|
Placebo
n=60 Participants
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Participants With a Change in Biomicroscopy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: change from baseline through end of study at Day 5Population: Summary of Best Corrected Visual Acuity (LogMar)
Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR). Distance visual acuity was assessed using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or equivalent chart. The subject should attempt to read each letter, line by line, left to right, beginning with line 1 at the top of the chart (20/200 line).The number of letters missed is multiplied by 0.02 and added to the baseline value to determine the logMAR visual acuity. Baseline is defined as the last line for which the subject reads at least one letter. logMAR units VA = Baseline value + (n x 0.02).
Outcome measures
| Measure |
AG-920
n=60 Participants
Articaine Sterile Topical Ophthalmic Solution (AG-920)
|
Placebo
n=60 Participants
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Mean Change in Visual Acuity
Study Eye
|
-0.0090 LogMar
Standard Deviation 0.07541
|
-0.0113 LogMar
Standard Deviation 0.04862
|
|
Mean Change in Visual Acuity
Non-Study Eye
|
-0.0110 LogMar
Standard Deviation 0.05977
|
-0.0110 LogMar
Standard Deviation 0.04821
|
Adverse Events
AG-920
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 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)
|
Placebo
n=60 participants at risk
Placebo Topical Ophthalmic Solution
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperaemia
|
6.7%
4/60 • Number of events 4 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed following the follow up phone call between Day 2 and Day 5. 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.
|
15.0%
9/60 • Number of events 9 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed following the follow up phone call between Day 2 and Day 5. 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.
|
|
Gastrointestinal disorders
Dysgeusia
|
6.7%
4/60 • Number of events 4 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed following the follow up phone call between Day 2 and Day 5. 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.
|
0.00%
0/60 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed following the follow up phone call between Day 2 and Day 5. 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.
|
|
General disorders
Instillation Site Pain
|
53.3%
32/60 • Number of events 32 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed following the follow up phone call between Day 2 and Day 5. 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.
|
6.7%
4/60 • Number of events 4 • Adverse events were documented from the time the subject was consented until the subject's participation in the study was completed following the follow up phone call between Day 2 and Day 5. 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 There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER