A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Completed · Phase 3 · Has a placebo group
Conditions studied: Anesthesia, Local
In brief
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..
Key facts
- Study ID
- NCT05501860
- Run by
- American Genomics, LLC
- People needed
- 249
- Starts
- 2022-07-30
- Expected to finish
- 2022-12-07
- Last updated by the study team
- 2024-10-09
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.
- 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.
- Specular microscopy subset subjects only:
- Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline
You may not qualify if…
- . 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.
- Have used topical, ocular medications in the 24 hours preceding dosing.
- Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
- Previous participation in a clinical study of AG-920.
- A current condition which could cause vision problems such as Pseudotumor Cerebri.
Where it is running
- American Genomics Site 1 — Newport Beach, California, United States
- American Genomics Site 2 — McAllen, Texas, United States
Full record on ClinicalTrials.gov
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