A Study of the Safety and Anesthetic Effect of AG-920 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

NCT04829344

AG-920-CS302

Details and patient eligibility

About

This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution.

Full description

This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. 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 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.

Enrollment: 120 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. Is male or a non-pregnant, non-lactating female aged 18 years or older.
3. Willing and able to follow instructions and be present for the required study visits.
4. Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.
5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
6. Certified as healthy by clinical assessment.
7. Verbal communication skills adequate to participate.
8. Able to tolerate bilateral instillation of Over-The-Counter artificial tear product based on investigator judgement.

Exclusion criteria

1. Have participated in an investigational study within the past 30 days.
2. Have a contraindication to local anesthetics.
3. Have known decreased corneal or conjunctival sensitivity.
4. Have had ocular surgery in either eye within the past 90 days.
5. Have had an intravitreal injection in either eye within 14 days.
6. Have ocular disease requiring punctual plugs or ocular inflammation.
7. Are currently using a systemic opioid or opiate analgesic or topical NSAID.
8. Cannot withhold their over the counter (OTC) artificial tear lubricant products for one hour preceding or following study medication.
9. Any condition, including alcohol or drug dependency, that would limit the subject's ability to comply with the procedures of the protocol.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 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%, Boric Acid, Mannitol, Sodium Acetate Trihydrate, Glacial Acetic Acid, and Edetate Disodium Dihydrate. The product formulation is adjusted to pH 4.5 to 5.0. Each subject randomized to AG-920 will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.

Treatment:

Drug: AG-920

Placebo

Placebo Comparator group

Description:

Placebo ophthalmic solution is identical to the active product, with the exception of the active ingredient. Each subject randomized to placebo will receive a single dose of 2 drops 30 seconds apart from a single vial into study eye.

Treatment:

Drug: Placebo