A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Completed · Phase 3 · Has a placebo group
Conditions studied: Anesthesia, Local
In brief
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.
Key facts
- Study ID
- NCT04829344
- Run by
- American Genomics, LLC
- People needed
- 120
- Starts
- 2021-03-30
- Expected to finish
- 2021-05-10
- Last updated by the study team
- 2024-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- American Genomics Site 2 — McAllen, Texas, United States
Full record on ClinicalTrials.gov
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