Clinical trial NCT04829344: A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Official title: A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, Local
Keywords: AG-920
articaine
septocaine
Intravitreal Injection
Lead sponsor: American Genomics, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes
timeFrame: 5 minutes post dose
Secondary outcomes:
measure: How Long it Takes One Dose of AG-920 to Anesthetize the Eye
timeFrame: 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.
measure: How Long One Dose of AG-920 Anesthetizes the Eye
timeFrame: 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: from randomization through study completion (up to 5 days) on average of 2 days.
measure: Number of Participants With a Change in Biomicroscopy
timeFrame: change from baseline through end of study at Day 5
measure: Change in Visual Acuity
timeFrame: change from baseline through end of study at Day 5
Other outcomes:
Locations:
city: McAllen
country: United States
facility: American Genomics Site 2
state: Texas
Study officials:
affiliation: Medical Expert
name: Martin Uram, MD
role: STUDY_DIRECTOR
References: