Anesthesia, LocalPhase 3NCT04829344
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
A Phase 3 study testing AG-920 in people with Anesthesia, Local, run by American Genomics, LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- AG-920
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 10 May 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to any study-related procedures being performed.
- Is male or a non-pregnant, non-lactating female aged 18 years or older.
- Willing and able to follow instructions and be present for the required study visits.
- Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.
- Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
- Certified as healthy by clinical assessment.
- Verbal communication skills adequate to participate.
- Able to tolerate bilateral instillation of Over-The-Counter artificial tear product based on investigator judgement.
Who cannot join
- Have participated in an investigational study within the past 30 days.
- Have a contraindication to local anesthetics.
- Have known decreased corneal or conjunctival sensitivity.
- Have had ocular surgery in either eye within the past 90 days.
- Have had an intravitreal injection in either eye within 14 days.
- Have ocular disease requiring punctual plugs or ocular inflammation.
Show all 9Show fewer
- Are currently using a systemic opioid or opiate analgesic or topical NSAID.
- Cannot withhold their over the counter (OTC) artificial tear lubricant products for one hour preceding or following study medication.
- Any condition, including alcohol or drug dependency, that would limit the subject's ability to comply with the procedures of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine 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.
Read the detailed description
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.
- Conditions
- Anesthesia, Local
- Being tested
- AG-920, Placebo
- Keywords
- AG-920, articaine, septocaine, Intravitreal Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-920Drug
Also called articaine
AG-920 Sterile Topical Ophthalmic Solution
PlaceboDrug
Placebo Topical Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AG-920 |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 5 minutes post dose
Secondary outcomes (5)
How Long it Takes One Dose of AG-920 to Anesthetize the Eye
Mean time to no pain score (onset)
Measured: 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
Mean duration of anesthetic effect
Measured: 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
Measured: 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.
Measured: 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).
Measured: change from baseline through end of study at Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start30 Mar 2021
- Primary completion6 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Genomics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Uram, MD, Study director, Medical Expert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829344
- Sponsor's protocol ID
- AG-920-CS302
- Status last verified
- Oct 2024
- First submitted
- 31 Mar 2021
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37192994
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution
- ClinicalTrials.gov ID
- NCT04829344
- Acronym / sponsor ID
- AG-920-CS302
- Conditions
- Anesthesia, Local
- Keywords
- AG-920, articaine, septocaine, Intravitreal Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- American Genomics, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| AG-920 | Experimental | Drug: AG-920Articaine 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 | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent prior to any study-related procedures being performed.
- Is male or a non-pregnant, non-lactating female aged 18 years or older.
- Willing and able to follow instructions and be present for the required study visits.
- Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.
- Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
Key exclusion criteria (9 listed)
- Have participated in an investigational study within the past 30 days.
- Have a contraindication to local anesthetics.
- Have known decreased corneal or conjunctival sensitivity.
- Have had ocular surgery in either eye within the past 90 days.
- Have had an intravitreal injection in either eye within 14 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG-920Also: articaineAG-920 Sterile Topical Ophthalmic Solution | Drug | AG-920 |
| PlaceboPlacebo Topical Ophthalmic Solution | Drug | Placebo |
Primary outcome
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
Time frame: 5 minutes post dose
Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."
5 secondary outcomes
How Long it Takes One Dose of AG-920 to Anesthetize the Eye
Time frame: 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
Time frame: 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)
Time frame: from randomization through study completion (up to 5 days) on average of 2 days.
Number of Participants With a Change in Biomicroscopy
Time frame: change from baseline through end of study at Day 5
Change in Visual Acuity
Time frame: change from baseline through end of study at Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37192994Gonzalez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Uram, MD study director
Medical Expert
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AG-920 in people with Anesthesia, Local, run by American Genomics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes (time frame: 5 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.