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

American Genomics

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Local

Treatments: Drug: AG-920; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05501860

AG-920-CS303

Details and patient eligibility

About

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..

Full description

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.

Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 ≥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, Septocaine®, 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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249 participants in 2 patient groups, including a placebo group

AG-920

Experimental group

Description:

Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%.

Treatment:

Drug: AG-920

Placebo

Placebo Comparator group

Description:

Placebo Sterile Topical Ophthalmic Solution

Treatment:

Drug: Placebo