Overview

A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution

Status:
Recruiting
Trial end date:
2023-01-31
Target enrollment:
0
Participant gender:
All
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..
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
American Genomics, LLC
Treatments:
Carticaine
Criteria
Inclusion Criteria:

1. Provide written informed consent prior to any study-related procedures being
performed.

2. Male or a non-pregnant, non-lactating female.

3. Healthy by clinical assessment, including ocular examination.

4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual
acuity (BCVA) of 20/200 or better in both eyes.

5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.

Specular microscopy subset subjects only:

6. Have a central corneal endothelial cell density of ā‰„1500 cells/mm2 at baseline

Exclusion Criteria:

1. . Have participated in an investigational study within the past 30 days.

2. Have a contraindication to local anesthetics, SeptocaineĀ®, or any component of the
IMP.

3. Have had ocular surgery or general surgery in either eye within the past 90 days.

4. Have had an intravitreal injection in either eye within 14 days of randomization.

5. Have ocular surface disease requiring punctal plugs.

6. Have evidence of any current ocular inflammation.

7. Current ocular allergy symptoms.

8. Have used topical, ocular medications in the 24 hours preceding dosing.

9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug
(NSAID) use within the past 30 days.

10. Previous participation in a clinical study of AG-920.

11. A current condition which could cause vision problems such as Pseudotumor Cerebri.