A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Condition: Anesthesia, Local
Intervention: AG-920; Placebo
Intervention description: AG-920 Sterile Topical Ophthalmic Solution; Placebo Topical Ophthalmic Solution
Intervention MeSH terms: Carticaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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 one (study) eye (2 drops 30 seconds apart).
Masking: Double (Participant, Investigator)
Masking description: The Investigator(s), Sponsor, and the subject will be masked to treatment assignment throughout the conduct of the study. Exceptions to this are limited to one statistician at the Contract Research Organization (CRO) who will prepare the randomization code, and three people at the Sponsor who will review the batch records and release product. None of these unmasked persons will be involved in the day to day execution of the study. The masking will be broken after database lock.
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AG-920; articaine; septocaine; Intravitreal Injection

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent prior to any study-related procedures being
             performed.

          2. Is male or a non-pregnant, non-lactating female aged 18 years or older.

          3. Willing and able to follow instructions and be present for the required study visits.

          4. Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity
             (BCVA) of 20/200 or better in each eye.

          5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.

          6. Certified as healthy by clinical assessment.

          7. Verbal communication skills adequate to participate.

          8. Able to tolerate bilateral instillation of Over-The-Counter artificial tear product
             based on investigator judgement.

        Exclusion Criteria:

          1. Have participated in an investigational study within the past 30 days.

          2. Have a contraindication to local anesthetics.

          3. Have known decreased corneal or conjunctival sensitivity.

          4. Have had ocular surgery in either eye within the past 90 days.

          5. Have had an intravitreal injection in either eye within 14 days.

          6. Have ocular disease requiring punctual plugs or ocular inflammation.

          7. Are currently using a systemic opioid or opiate analgesic or topical NSAID.

          8. Cannot withhold their over the counter (OTC) artificial tear lubricant products for
             one hour preceding or following study medication.

          9. Any condition, including alcohol or drug dependency, that would limit the subject's
             ability to comply with the procedures of the protocol.