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

Primary Purpose

Anesthesia, Local

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AG-920
Placebo
Sponsored by
American Genomics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia, Local focused on measuring AG-920, Articaine, Septocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Provide written informed consent prior to any study-related procedures being performed.
  2. Male or a non-pregnant, non-lactating female.
  3. Healthy by clinical assessment, including ocular examination.
  4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.

  5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.

    Specular microscopy subset subjects only:

  6. Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline

Exclusion Criteria:

  1. . Have participated in an investigational study within the past 30 days.
  2. Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
  3. Have had ocular surgery or general surgery in either eye within the past 90 days.
  4. Have had an intravitreal injection in either eye within 14 days of randomization.
  5. Have ocular surface disease requiring punctal plugs.
  6. Have evidence of any current ocular inflammation.
  7. Current ocular allergy symptoms.
  8. Have used topical, ocular medications in the 24 hours preceding dosing.
  9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
  10. Previous participation in a clinical study of AG-920.
  11. A current condition which could cause vision problems such as Pseudotumor Cerebri.

Sites / Locations

  • American Genomics Site 1
  • American Genomics Site 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AG-920

Placebo

Arm Description

Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.

Placebo Sterile Topical Ophthalmic Solution

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2022
Last Updated
January 30, 2023
Sponsor
American Genomics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05501860
Brief Title
A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Official Title
A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
December 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Genomics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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..
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local
Keywords
AG-920, Articaine, Septocaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
The study is double masked.
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AG-920
Arm Type
Experimental
Arm Description
Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Sterile Topical Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
AG-920
Other Intervention Name(s)
articaine
Intervention Description
AG-920 Sterile Topical Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Sterile Topical Ophthalmic Solution
Primary Outcome Measure Information:
Title
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Description
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).
Time Frame
From randomization through study completion (up to 4 days following treatment); 90 days following treatment for subjects participating in specular microscopy.
Secondary Outcome Measure Information:
Title
Mean change from baseline in corneal endothelial cell density after treatment with AG-920
Description
Endothelial cell count (and corneal morphology) will be summarized by continuous summaries
Time Frame
From screening through study completion (90 days following treatment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: . 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Uram, MD
Organizational Affiliation
Medical Expert
Official's Role
Study Director
Facility Information:
Facility Name
American Genomics Site 1
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
American Genomics Site 2
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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