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This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution.
This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. 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 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.
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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%, 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. |
|
| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-920 | Drug | AG-920 Sterile Topical Ophthalmic Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes | Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO." | 5 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| How Long it Takes One Dose of AG-920 to Anesthetize the Eye | Mean time to no pain score (onset) | 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. |
| How Long One Dose of AG-920 Anesthetizes the Eye |
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Inclusion Criteria:
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 2 | McAllen | Texas | 78503 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192994 | Derived | Gonzalez VH, Wirta DL, Uram M, Schupp A, Widmann M, Novack GD. Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution. Clin Ophthalmol. 2023 May 10;17:1357-1365. doi: 10.2147/OPTH.S409241. eCollection 2023. |
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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.
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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%, 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 |
| FG001 | 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 |
| 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%, 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 |
| Units | Counts |
|---|---|
| Participants |
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| 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 | The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes | Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO." | Posted | Count of Participants | Participants | 5 minutes post dose |
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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.
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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%, 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctival hyperemia | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
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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 | Jan 21, 2021 | Apr 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2021 | 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 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 seconds apart).
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The Investigator(s), Sponsor, and the subject will be masked to treatment assignment throughout the conduct of the study. Exceptions to this are limited to one statistician at the Contract Research Organization (CRO) who will prepare the randomization code, and three people at the Sponsor who will review the batch records and release product. None of these unmasked persons will be involved in the day to day execution of the study. The masking will be broken after database lock.
| Placebo | Drug | Placebo Topical Ophthalmic Solution |
|
Mean duration of anesthetic effect |
| 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Total number of participants with TEAEs | from randomization through study completion (up to 5 days) on average of 2 days. |
| Number of Participants With a Change in Biomicroscopy | 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. | change from baseline through end of study at Day 5 |
| Change in Visual Acuity | Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR). | change from baseline through end of study at Day 5 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BCVA LogMar Study Eye | Mean | Standard Deviation | LogMar |
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| BCVA LogMar Fellow Eye | Mean | Standard Deviation | LogMar |
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| Color of Iris | Count of Participants | Participants |
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| IOP Study Eye | Mean | Standard Deviation | mmHg |
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| IOP Fellow Eye | Mean | Standard Deviation | mmHg |
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| 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 |
|
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| Secondary | How Long it Takes One Dose of AG-920 to Anesthetize the Eye | Mean time to no pain score (onset) | Posted | Mean | Standard Deviation | minutes | 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. |
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|
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| Secondary | How Long One Dose of AG-920 Anesthetizes the Eye | Mean duration of anesthetic effect | Posted | Mean | Standard Deviation | minutes | 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. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Total number of participants with TEAEs | Posted | Count of Participants | Participants | from randomization through study completion (up to 5 days) on average of 2 days. |
|
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|
| Secondary | Number of Participants With a Change in Biomicroscopy | 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. | Slit Lamp Examination Assessment change from baseline | Posted | Count of Participants | Participants | change from baseline through end of study at Day 5 |
|
|
|
| Secondary | Change in Visual Acuity | Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR). | Posted | Mean | Standard Deviation | LogMAR | change from baseline through end of study at Day 5 |
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|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 7 |
| 60 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 2 | 60 |
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.
| D006571 |
| Heterocyclic Compounds |