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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. |
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| 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 Number 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 |
|---|---|---|
| Time in Minutes 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. |
| To Evaluate 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 1 | Newport Beach | California | 92663 | 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 (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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AG-920 | Articaine Sterile Topical Ophthalmic Solution (AG-920) |
| FG001 | 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 Number 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." | Summary of Proportion of Subjects with No Pain at 5 Minutes | 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 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.
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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) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Uram, MD | American Genomics, LLC | 848-444-0665 | martin@amgenomics.net |
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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 | Sep 15, 2020 | Aug 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 17, 2020 | Aug 4, 2022 | 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) | 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). | from randomization through study completion (up to 4 days following treatment) |
| Number of Participants With a Change in Biomicroscopy | 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. | change from baseline through end of study at Day 5 |
| Mean 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). 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). | 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 | years |
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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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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Time in Minutes of AG-920 to Anesthetize the Eye | Mean time to no pain score (onset) | Summary of Time to No Pain (Onset of Anesthesia Effect in Minutes) | 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 | To Evaluate How Long One Dose of AG-920 Anesthetizes the Eye | Mean duration of anesthetic effect | Summary of Pinch Test for Duration (in Minutes) 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) | 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). | Summary of Treatment Emergent Adverse Events | Posted | Number | participants | from randomization through study completion (up to 4 days following treatment) |
|
|
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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 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. | Slit Lamp Examination Assessment change from baseline | Posted | Count of Participants | Participants | change from baseline through end of study at Day 5 |
|
|
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| Secondary | Mean 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). 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). | Summary of Best Corrected Visual Acuity (LogMar) | Posted | Mean | Standard Deviation | LogMar | change from baseline through end of study at Day 5 |
|
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| 60 |
| 0 |
| 60 |
| 34 |
| 60 |
| EG001 | Placebo | Placebo Topical Ophthalmic Solution | 0 | 60 | 0 | 60 | 13 | 60 |
| Dysgeusia | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Instillation Site Pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
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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.
| D006571 |
| Heterocyclic Compounds |
| Non-ocular TEAEs |
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