A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution

NCT04829344 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AG-920-CS302
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

AG-920; articaine; septocaine; Intravitreal Injection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• How Long it Takes One Dose of AG-920 to Anesthetize the Eye

  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

  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)

  from randomization through study completion (up to 5 days) on average of 2 days.

• Number of Participants With a Change in Biomicroscopy

  change from baseline through end of study at Day 5

• Change in Visual Acuity

  change from baseline through end of study at Day 5

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

AG-920 DRUG

AG-920 Sterile Topical Ophthalmic Solution

Also known as: articaine

AG-920

Placebo DRUG

Placebo Topical Ophthalmic Solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• American Genomics, LLC: lead

Study Sites (1)

American Genomics Site 2

McAllen, Texas, 78503, United States

Location

Related Publications (1)

• 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.

  PMID: 37192994 DERIVED

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michelle Widmann
• Organization: American Genomics, LLC

mwidmann@calclinicalsolutions.com

919-600-1819

Study Officials

• Martin Uram, MD

  Medical Expert

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: March 30, 2021
• Primary Completion: May 6, 2021
• Study Completion: May 10, 2021
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)