Anesthesia, LocalPhase 3NCT05501860

A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution

A Phase 3 study testing AG-920 in people with Anesthesia, Local, run by American Genomics, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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.. 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: 249 participants
Where: 2 sitesUnited States
Study dates: 30 Jul 2022to 7 Dec 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 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.
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

Who cannot join

. Have participated in an investigational study within the past 30 days.
Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
Have had ocular surgery or general surgery in either eye within the past 90 days.
Have had an intravitreal injection in either eye within 14 days of randomization.
Have ocular surface disease requiring punctal plugs.
Have evidence of any current ocular inflammation.

Show all 11Show fewer

Current ocular allergy symptoms.
Have used topical, ocular medications in the 24 hours preceding dosing.
Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
Previous participation in a clinical study of AG-920.
A current condition which could cause vision problems such as Pseudotumor Cerebri.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

American Genomics Site 2
McAllen, Texas, 78503
American Genomics Site 1
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution

Read the detailed description

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.

Conditions: Anesthesia, Local
Being tested: AG-920, Placebo
Keywords: AG-920, Articaine, Septocaine

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 Sterile Topical Ophthalmic Solution

Study groups in NCT05501860
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
Placebo	Placebo comparator	Placebo Sterile Topical Ophthalmic Solution Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.

Secondary outcomes (1)

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
Measured: From Day 1 (treatment day) to 90 days following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 20227 Dec 2022

First posted16 Aug 2022
Study start30 Jul 2022
Primary completion7 Dec 2022
Study completion7 Dec 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.
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 2:1 ratio to receive a single dose of AG-920 or placebo into one (study) eye (2 drops 30 seconds apart).
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05501860
Sponsor's protocol ID: AG-920-CS303
Status last verified: Apr 2024
First submitted: 12 Aug 2022
Last updated: 9 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution
ClinicalTrials.gov ID: NCT05501860
Acronym / sponsor ID: AG-920-CS303
Conditions: Anesthesia, Local
Keywords: AG-920, Articaine, Septocaine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: American Genomics, LLCIndustry (pharma, biotech, devices)
Study start: 30 Jul 2022 (actual)
Primary completion: 7 Dec 2022 (actual)
Study completion: 7 Dec 2022 (actual)
First posted: 16 Aug 2022 (actual)
Results: Posted 9 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, 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 2:1 ratio to receive a single dose of AG-920 or 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%.
Placebo	Placebo comparator	Drug: PlaceboPlacebo Sterile Topical Ophthalmic Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (11 listed)

. Have participated in an investigational study within the past 30 days.
Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
Have had ocular surgery or general surgery in either eye within the past 90 days.
Have had an intravitreal injection in either eye within 14 days of randomization.
Have ocular surface disease requiring punctal plugs.

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 Sterile Topical Ophthalmic Solution	Drug	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.
TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC.

1 secondary outcome

Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920
Time frame: From Day 1 (treatment day) to 90 days following treatment

Results and safety

Results posted to the registry on 9 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AG-920	166	165
Placebo	83	82

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.. Count of participants. Unit: Participants

Measure	AG-920 n = 166	Placebo n = 83
Value	40	13

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AG-920	0 of 166 (0%)	38 of 166 (22.9%)	0 of 166
Placebo	0 of 83 (0%)	10 of 83 (12%)	0 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

2 sites 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 2 sites 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 7 inclusion and 11 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 9 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 2 sites 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 9 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.). 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 NCT05501860.

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 9 Oct 2024.