Status:
COMPLETED
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Lead Sponsor:
American Genomics, LLC
Conditions:
Anesthesia, Local
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04513652
Start Date
September 3 2020
End Date
December 17 2020
Last Update
September 28 2022
Active Locations (1)
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1
American Genomics Site 1
Newport Beach, California, United States, 92663