- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829344
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
May 4, 2022 updated by: American Genomics, LLC
A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution
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.
Study Overview
Detailed Description
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.
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 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye.
Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
McAllen, Texas, United States, 78503
- American Genomics Site 2
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AG-920
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.
|
AG-920 Sterile Topical Ophthalmic Solution
Other Names:
|
Placebo Comparator: Placebo
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.
|
Placebo Topical Ophthalmic Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients who experienced ocular anesthesia following treatment of AG-920 compared to placebo at 5 minutes
Time Frame: 5 minutes post dose
|
Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."
|
5 minutes post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate how long it takes one dose of AG-920 to anesthetize the eye
Time Frame: 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.
|
Mean time to no pain score (onset)
|
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.
|
To evaluate how long one dose of AG-920 anesthetizes the eye
Time Frame: 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.
|
Mean duration of anesthetic effect
|
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)
Time Frame: from randomization through study completion (up to 4 days following treatment)
|
TEAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC).
Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).
|
from randomization through study completion (up to 4 days following treatment)
|
Change in biomicroscopy
Time Frame: change from baseline through end of study at Day 5
|
Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured time point using discrete summary statistics.
|
change from baseline through end of study at Day 5
|
Change in visual acuity
Time Frame: change from baseline through end of study at Day 5
|
Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR).
|
change from baseline through end of study at Day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2021
Primary Completion (Actual)
May 6, 2021
Study Completion (Actual)
May 10, 2021
Study Registration Dates
First Submitted
March 31, 2021
First Submitted That Met QC Criteria
March 31, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG-920-CS302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia, Local
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMNot yet recruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | AnesthesiaGermany
-
Grünenthal GmbHTerminatedAnalgesia | Anesthesia, Local | AnesthesiaNetherlands
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMRecruiting
-
University Health Network, TorontoRecruiting
-
Kfir SiagNot yet recruiting
-
Hams Hamed AbdelrahmanCompleted
-
University of BaghdadActive, not recruiting
Clinical Trials on AG-920
-
American Genomics, LLCCompleted
-
Sangamo TherapeuticsEnrolling by invitationFabry Disease | Fabry Disease, Cardiac VariantUnited States, Australia, United Kingdom
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedAcute Ischemic Stroke
-
Luminary TherapeuticsNationwide ChildrenNot yet recruitingSystemic Lupus Erythematosus
-
Sangamo TherapeuticsActive, not recruitingFabry DiseaseUnited States, United Kingdom, Taiwan, Australia, Germany, Italy, Canada
-
Luminary TherapeuticsCase Comprehensive Cancer CenterRecruitingLymphoma, Non-Hodgkin Lymphoma, B-CellUnited States
-
American Genomics, LLCCompleted
-
Mashhad University of Medical SciencesCompletedAnxiety | Labor Pain
-
American Genomics, LLCCompletedAnesthesia, LocalUnited States
-
Vedic Lifesciences Pvt. Ltd.Enovate Biolife Pvt LtdCompleted