Phase 3
N=249
A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT05501860 ↗Enrolled (actual)
249
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 40; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AG-920 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Genomics, LLC
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
40; 13 | — |
| SECONDARY Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920 |
-23.83; -44.33 | — |
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..
Eligibility Criteria
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.
Specular microscopy subset subjects only:
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT05501860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.