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

Phase 3

Completed

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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
AG-920	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes	5 minutes post dose	Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."

Secondary Outcome Measures

Name	Time	Method
Change in Visual Acuity	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).
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.	Mean time to no pain score (onset)
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.	Mean duration of anesthetic effect
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	from randomization through study completion (up to 5 days) on average of 2 days.	Total number of participants with TEAEs
Number of Participants With a Change in Biomicroscopy	change from baseline through end of study at Day 5	Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured timepoint using discrete summary statistics. Clinician examined the eyelid, conjunctiva, cornea, anterior chamber, iris, pupil, and lens of the eye with the aid of a slit lamp.