Anesthesia, Local
Conditions
Keywords
AG-920, Articaine, Septocaine
Brief summary
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..
Detailed description
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations. Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.
Interventions
DRUGPlacebo
Placebo Sterile Topical Ophthalmic Solution
DRUGAG-920
AG-920 Sterile Topical Ophthalmic Solution
Sponsors
American Genomics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The study is double masked.
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 2:1 ratio to receive a single dose of AG-920 or placebo into one (study) eye (2 drops 30 seconds apart).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to any study-related procedures being performed. 2. Male or a non-pregnant, non-lactating female. 3. Healthy by clinical assessment, including ocular examination. 4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes. 5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg. Specular microscopy subset subjects only: 6. Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline
Exclusion criteria
1. . Have participated in an investigational study within the past 30 days. 2. Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP. 3. Have had ocular surgery or general surgery in either eye within the past 90 days. 4. Have had an intravitreal injection in either eye within 14 days of randomization. 5. Have ocular surface disease requiring punctal plugs. 6. Have evidence of any current ocular inflammation. 7. Current ocular allergy symptoms. 8. Have used topical, ocular medications in the 24 hours preceding dosing. 9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days. 10. Previous participation in a clinical study of AG-920. 11. A current condition which could cause vision problems such as Pseudotumor Cerebri.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy. | TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920 | From Day 1 (treatment day) to 90 days following treatment | Endothelial cell count (and corneal morphology) will be summarized by continuous summaries |
Countries
United States
Participant flow
Recruitment details
Studied Period: 30 July 2022 to 7 December 2022 @ two study centers in the US.
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 | 166 |
| Placebo Placebo Sterile Topical Ophthalmic Solution
Placebo: Placebo Sterile Topical Ophthalmic Solution | 83 |
| Total | 249 |
Baseline characteristics
| Characteristic | AG-920 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 9 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 74 Participants | 223 Participants |
| Age, Continuous | 39.4 years STANDARD_DEVIATION 16.3 | 40.1 years STANDARD_DEVIATION 15.8 | 39.6 years STANDARD_DEVIATION 16.1 |
| BCVA LogMar BCVA LogMar Fellow Eye | 0.0 LogMar STANDARD_DEVIATION 0.2 | 0.0 LogMar STANDARD_DEVIATION 0.2 | 0.0 LogMar STANDARD_DEVIATION 0.2 |
| BCVA LogMar BCVA LogMar Study Eye | 0.0 LogMar STANDARD_DEVIATION 0.2 | 0.0 LogMar STANDARD_DEVIATION 0.2 | 0.0 LogMar STANDARD_DEVIATION 0.2 |
| Color of Iris Blue | 11 Participants | 7 Participants | 18 Participants |
| Color of Iris Brown | 128 Participants | 66 Participants | 194 Participants |
| Color of Iris Green | 13 Participants | 3 Participants | 16 Participants |
| Color of Iris Hazel | 14 Participants | 7 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 118 Participants | 56 Participants | 174 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 27 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 5 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 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 | 153 Participants | 75 Participants | 228 Participants |
| Region of Enrollment United States | 166 participants | 83 participants | 249 participants |
| Sex: Female, Male Female | 106 Participants | 48 Participants | 154 Participants |
| Sex: Female, Male Male | 60 Participants | 35 Participants | 95 Participants |
| Study Eye Left Eye (OS) | 83 Participants | 42 Participants | 125 Participants |
| Study Eye Right Eye (OD) | 83 Participants | 41 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 83 |
| other Total, other adverse events | 38 / 166 | 10 / 83 |
| serious Total, serious adverse events | 0 / 166 | 0 / 83 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AG-920 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 40 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 13 Participants |
Secondary
Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920
Endothelial cell count (and corneal morphology) will be summarized by continuous summaries
Time frame: From Day 1 (treatment day) to 90 days following treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AG-920 | Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920 | -23.83 cells/mm2 | Standard Deviation 92.18 |
| Placebo | Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920 | -44.33 cells/mm2 | Standard Deviation 85.19 |