A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution (NCT04829344) | Clinical Trial Compass
CompletedPhase 3
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
United States120 participantsStarted 2021-03-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes