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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..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG-920 | Experimental | Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%. |
|
| Placebo | Placebo Comparator | Placebo Sterile Topical Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-920 | Drug | AG-920 Sterile Topical Ophthalmic Solution |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Day 1 (treatment day) to 90 days following treatment |
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Inclusion Criteria:
Provide written informed consent prior to any study-related procedures being performed.
Male or a non-pregnant, non-lactating female.
Healthy by clinical assessment, including ocular examination.
Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
Specular microscopy subset subjects only:
Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Uram, MD | Medical Expert | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Genomics Site 1 | Newport Beach | California | 92663 | United States | ||
| American Genomics Site 2 |
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Studied Period: 30 July 2022 to 7 December 2022 @ two study centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Placebo Sterile Topical Ophthalmic Solution Placebo: Placebo Sterile Topical Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy. |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA version 25.0 | Systematic Assessment | General disorders and administration site conditions - Instillation site pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Widmann | American Genomics, LLC | 919-600-1819 | mwidmann@calclinicalsolutions.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2022 | Apr 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2023 | Apr 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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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).
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The study is double masked.
| Placebo | Drug | Placebo Sterile Topical Ophthalmic Solution |
|
| McAllen |
| Texas |
| 78503 |
| United States |
Placebo Sterile Topical Ophthalmic Solution Placebo: Placebo Sterile Topical Ophthalmic Solution |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Study Eye | Count of Participants | Participants |
|
| Color of Iris | Count of Participants | Participants |
|
| BCVA LogMar | Mean | Standard Deviation | LogMar |
|
| OG001 | Placebo | Placebo Sterile Topical Ophthalmic Solution Placebo: Placebo Sterile Topical Ophthalmic Solution |
|
|
| 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 | Posted | Mean | Standard Deviation | cells/mm2 | From Day 1 (treatment day) to 90 days following treatment |
|
|
|
| 0 |
| 166 |
| 0 |
| 166 |
| 38 |
| 166 |
| EG001 | Placebo | Placebo Sterile Topical Ophthalmic Solution Placebo: Placebo Sterile Topical Ophthalmic Solution | 0 | 83 | 0 | 83 | 10 | 83 |
|
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.
| D006571 |
| Heterocyclic Compounds |