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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: AG-920
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AG-920<br>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<br>* AG-920 Sterile Topical Ophthalmic Solution<br>* Other names: articaine;|
| Placebo Comparator: Placebo<br>Placebo Sterile Topical Ophthalmic Solution | Drug: Placebo<br>* Placebo Sterile Topical Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | From randomization through study completion (up to 4 days following treatment); 90 days following treatment for subjects participating in specular microscopy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From screening through study completion (90 days following treatment). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AG-920, Articaine, Septocaine