Trial Outcomes & Findings for A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution (NCT NCT05501860)
NCT ID: NCT05501860
Last Updated: 2024-10-09
Results Overview
TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
249 participants
Primary outcome timeframe
From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.
Results posted on
2024-10-09
Participant Flow
Studied Period: 30 July 2022 to 7 December 2022 @ two study centers in the US.
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
|
Placebo
Placebo Sterile Topical Ophthalmic Solution
Placebo: Placebo Sterile Topical Ophthalmic Solution
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
83
|
|
Overall Study
Specular Microscopy Population
|
13
|
3
|
|
Overall Study
COMPLETED
|
165
|
82
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Baseline characteristics by cohort
| Measure |
AG-920
n=166 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
|
Placebo
n=83 Participants
Placebo Sterile Topical Ophthalmic Solution
Placebo: Placebo Sterile Topical Ophthalmic Solution
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
149 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 16.3 • n=99 Participants
|
40.1 years
STANDARD_DEVIATION 15.8 • n=107 Participants
|
39.6 years
STANDARD_DEVIATION 16.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
118 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
75 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
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
18 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
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
228 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
|
166 participants
n=99 Participants
|
83 participants
n=107 Participants
|
249 participants
n=206 Participants
|
|
Study Eye
Left Eye (OS)
|
83 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Study Eye
Right Eye (OD)
|
83 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Color of Iris
Blue
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Color of Iris
Brown
|
128 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Color of Iris
Green
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Color of Iris
Hazel
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
BCVA LogMar
BCVA LogMar Study Eye
|
0.0 LogMar
STANDARD_DEVIATION 0.2 • n=99 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.2 • n=107 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.2 • n=206 Participants
|
|
BCVA LogMar
BCVA LogMar Fellow Eye
|
0.0 LogMar
STANDARD_DEVIATION 0.2 • n=99 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.2 • n=107 Participants
|
0.0 LogMar
STANDARD_DEVIATION 0.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.Population: The safety population is defined as all subjects which were randomized and who received at least one drop of the dose (2 drops) of the study medication. The ITT population is defined as all subjects who were randomized to treatment and have received at least one dose (two drops) of the study medication. In this study, the ITT and safety populations were found to be identical.
TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC.
Outcome measures
| Measure |
AG-920
n=166 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
|
Placebo
n=83 Participants
Placebo Sterile Topical Ophthalmic Solution
Placebo: Placebo Sterile Topical Ophthalmic Solution
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
40 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (treatment day) to 90 days following treatmentEndothelial cell count (and corneal morphology) will be summarized by continuous summaries
Outcome measures
| Measure |
AG-920
n=13 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
|
Placebo
n=3 Participants
Placebo Sterile Topical Ophthalmic Solution
Placebo: Placebo Sterile Topical Ophthalmic Solution
|
|---|---|---|
|
Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920
|
-23.83 cells/mm2
Standard Deviation 92.18
|
-44.33 cells/mm2
Standard Deviation 85.19
|
Adverse Events
AG-920
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AG-920
n=166 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%.
AG-920: AG-920 Sterile Topical Ophthalmic Solution
|
Placebo
n=83 participants at risk
Placebo Sterile Topical Ophthalmic Solution
Placebo: Placebo Sterile Topical Ophthalmic Solution
|
|---|---|---|
|
General disorders
Instillation site pain
|
22.9%
38/166 • Number of events 38 • Adverse events were reported starting from the time of signing the informed consent until the end of the study assessment (follow up phone call at day 2-5 or day 90 for specular microscopy subjects).
|
12.0%
10/83 • Number of events 10 • Adverse events were reported starting from the time of signing the informed consent until the end of the study assessment (follow up phone call at day 2-5 or day 90 for specular microscopy subjects).
|
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 multicenter 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