Anesthesia, LocalPhase 3NCT05325853
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
A Phase 3 study testing AG-920 and Proparacaine Ophthalmic in people with Anesthesia, Local, run by American Genomics, LLC at 1 site in United States.
Trial summary
A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution. Read more about this study
- Who is it for?
- Ages Up to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- AG-920 and Proparacaine Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 27 May 2022
- 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 Up to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pre-pubescent with no childbearing potential
- Capable of undergoing an eye exam
- Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
- Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
- Have a healthy, normal cornea.
Who cannot join
- Have participated in an investigational study (drug or device) within the past 30 days.
- Have a known contraindication to local anesthetics.
- Children with known autism spectrum disorders or known to have heightened sensitivity.
- Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
- Have low visual acuity
- Manifest nystagmus
Show all 9Show fewer
- Have had ocular surgery or general surgery within the past 45 days.
- Have had an intravitreal injection in either eye within 14 days of randomization.
- Have ocular surface disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Masked, Active-Controlled, Parallel-Group Evaluation of Safety and the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution (AG-920) in a Pediatric Population
A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.
Read the detailed description
A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 compared to Proparacaine. In this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). Subjects who 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 Proparacaine into one (study) eye.
Each dose of AG-920 or Proparacaine HCl will consist of two drops in the study eye. After the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.
- Conditions
- Anesthesia, Local
- Being tested
- AG-920, Proparacaine Ophthalmic
- Keywords
- AG-920, Articaine, Septocaine, Intravitreal Injection, Proparacaine
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
Proparacaine OphthalmicDrug
Also called Proparacaine
0.5% Proparacaine Hydrochloride
| 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%. Receives: Drug: AG-920 |
| Proparacaine | Active comparator | 0.5% Proparacaine Hydrochloride Receives: Drug: Proparacaine Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Participants in Which an Eye Exam Was Able to be Performed
Was the investigator was able to perform the eye examination without additional anesthesia
Measured: Two to four minutes following treatment (last drop) of IMP
Secondary outcomes (1)
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. Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).
Measured: From randomization through study completion (up to 4 days following treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start6 Apr 2022
- Primary completion27 May 2022
- Study completion27 May 2022
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 proparacaine into one (study) eye (2 drops 30 seconds apart).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 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
- NCT05325853
- Sponsor's protocol ID
- AG-920-CS304
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2022
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gonzalez VH, Uram M, Schupp A, Widmann M, Novack GD. AG-920 (Articaine) Ophthalmic Solution: A Masked, Active-Controlled Evaluation of Its Local Anesthetic Efficacy and Safety in Pediatric Patients. J Ocul Pharmacol Ther. 2024 Jun;40(5):293-296. doi: 10.1089/jop.2023.0187. Epub 2024 Apr 22.
PubMed 38647654
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Masked, Active-Controlled, Parallel-Group Evaluation of Safety and the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution (AG-920) in a Pediatric Population
- ClinicalTrials.gov ID
- NCT05325853
- Acronym / sponsor ID
- AG-920-CS304
- Conditions
- Anesthesia, Local
- Keywords
- AG-920, Articaine, Septocaine, Intravitreal Injection, Proparacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- American Genomics, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Posted 25 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.
Detailed description
A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 compared to Proparacaine. In this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). Subjects who 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 Proparacaine into one (study) eye.
Each dose of AG-920 or Proparacaine HCl will consist of two drops in the study eye. After the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- 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 proparacaine 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%. |
| Proparacaine | Active comparator | Drug: Proparacaine Ophthalmic0.5% Proparacaine Hydrochloride |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pre-pubescent with no childbearing potential
- Capable of undergoing an eye exam
- Subject's legally appointed and authorized representative willing to sign and date an informed consent form (ICF) and, where appropriate, the subject willing to sign an assent form prior to any study-related procedures being performed.
- Parent/legal guardian and subject are willing and able to follow instructions and can be present for the required study visits and Follow-up Phone Call for the duration of the study.
- Have a healthy, normal cornea.
Key exclusion criteria (9 listed)
- Have participated in an investigational study (drug or device) within the past 30 days.
- Have a known contraindication to local anesthetics.
- Children with known autism spectrum disorders or known to have heightened sensitivity.
- Corneal pathology that would make the corneal sensitivity lower/higher or make the test hard to perform or interpret.
- Have low visual acuity
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 |
| Proparacaine OphthalmicAlso: Proparacaine0.5% Proparacaine Hydrochloride | Drug | Proparacaine |
Primary outcome
The Proportion of Participants in Which an Eye Exam Was Able to be Performed
Time frame: Two to four minutes following treatment (last drop) of IMP
Was the investigator was able to perform the eye examination without additional anesthesia
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From randomization through study completion (up to 4 days following treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38647654Gonzalez VH, Uram M, Schupp A, Widmann M, Novack GD. AG-920 (Articaine) Ophthalmic Solution: A Masked, Active-Controlled Evaluation of Its Local Anesthetic Efficacy and Safety in Pediatric Patients. J Ocul Pharmacol Ther. 2024 Jun;40(5):293-296. doi: 10.1089/jop.2023.0187. Epub 2024 Apr 22.
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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 and Proparacaine Ophthalmic 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 5 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 25 Oct 2023. 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. 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 25 Oct 2023). 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 Proportion of Participants in Which an Eye Exam Was Able to be Performed (time frame: Two to four minutes following treatment (last drop) of IMP). 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 NCT05325853, 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 25 Oct 2023.