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

Anesthesia, Local Clinical Trial

Official title:

A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513652
• Other study ID #: AG-920-CS301
• Status: Completed
• Phase: Phase 3
• Start date: September 3, 2020
• Est. completion date: December 17, 2020

Study information

• Verified date: August 2022
• Source: American Genomics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 17, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• AG-920
AG-920 Sterile Topical Ophthalmic Solution
• Placebo
Placebo Topical Ophthalmic Solution

Locations

Country	Name	City	State
United States	American Genomics Site 1	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
American Genomics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes	Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."	5 minutes post dose
Secondary	Time in Minutes of AG-920 to Anesthetize the Eye	Mean time to no pain score (onset)	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.
Secondary	To Evaluate How Long One Dose of AG-920 Anesthetizes the Eye	Mean duration of anesthetic effect	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.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	TEAEs will be summarized by treatment group using frequency and percent for each system organ class and preferred term within each system, organ and class (SOC). Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).	from randomization through study completion (up to 4 days following treatment)
Secondary	Number of Participants With a Change in Biomicroscopy	Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured time point using discrete summary statistics. Clinician examined the eyelid, conjunctiva, cornea, anterior chamber, iris, pupil and lens of the eye with the aid of a slit lamp.	change from baseline through end of study at Day 5
Secondary	Mean Change in Visual Acuity	Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR). Distance visual acuity was assessed using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or equivalent chart. The subject should attempt to read each letter, line by line, left to right, beginning with line 1 at the top of the chart (20/200 line).The number of letters missed is multiplied by 0.02 and added to the baseline value to determine the logMAR visual acuity. Baseline is defined as the last line for which the subject reads at least one letter. logMAR units VA = Baseline value + (n x 0.02).	change from baseline through end of study at Day 5