A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution (NCT05501860) | Clinical Trial Compass
CompletedPhase 3
A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
United States249 participantsStarted 2022-07-30
Plain-language summary
A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..
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.
✓. Male or a non-pregnant, non-lactating female.
✓. Healthy by clinical assessment, including ocular examination.
✓. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
✓. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
✓. Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline
Exclusion criteria
✕. . Have participated in an investigational study within the past 30 days.
✕. Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
✕. Have had ocular surgery or general surgery in either eye within the past 90 days.
✕. Have had an intravitreal injection in either eye within 14 days of randomization.
✕. Have ocular surface disease requiring punctal plugs.
✕. Have evidence of any current ocular inflammation.
✕. Current ocular allergy symptoms.
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What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.