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

NCT05501860 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AG-920-CS303
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 2

Brief 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..

Conditions

Anesthesia, Local

Keywords

AG-920; Articaine; Septocaine

Outcome Measures

Primary 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.

  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

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

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%.

Drug: AG-920

Placebo

PLACEBO COMPARATOR

Placebo Sterile Topical Ophthalmic Solution

Drug: Placebo

Interventions

AG-920 DRUG

AG-920 Sterile Topical Ophthalmic Solution

Also known as: articaine

AG-920

Placebo DRUG

Placebo Sterile 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• American Genomics, LLC: lead

Study Sites (2)

American Genomics Site 1

Newport Beach, California, 92663, United States

Location

American Genomics Site 2

McAllen, Texas, 78503, United States

Location

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is double masked.
• 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 2:1 ratio to receive a single dose of AG-920 or placebo into one (study) eye (2 drops 30 seconds apart).

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: July 30, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-04

Locations

US (2)