A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2020-12-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 one (study) eye (2 drops 30 seconds apart).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

The Investigator(s), Sponsor, and the subject will be masked to treatment assignment throughout the conduct of the study. Exceptions to this are limited to one statistician at the Contract Research Organization (CRO) who will prepare the randomization code, and three people at the Sponsor who will review the batch records and release product. None of these unmasked persons will be involved in the day to day execution of the study. The masking will be broken after database lock.

Study Groups

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AG-920

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.

Group Type EXPERIMENTAL

AG-920

Intervention Type DRUG

AG-920 Sterile Topical Ophthalmic Solution

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Topical Ophthalmic Solution

Interventions

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AG-920

AG-920 Sterile Topical Ophthalmic Solution

Intervention Type DRUG

Placebo

Placebo Topical Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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articaine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes