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Completed

NCT Number: NCT04513652

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

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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Key information

Conditions

Anesthesia, Local

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

American Genomics Site 1

Newport Beach, California, 92663, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AG-920

Drug

AG-920 Sterile Topical Ophthalmic Solution

Other names: articaine

Placebo

Drug

Placebo Topical Ophthalmic Solution

Primary outcomes

  1. The Number of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes

    Time frame: 5 minutes post dose

    Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO."

Secondary outcomes

  1. Time in Minutes of AG-920 to Anesthetize the Eye

    Time frame: 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.

    Mean time to no pain score (onset)

  2. To Evaluate How Long One Dose of AG-920 Anesthetizes the Eye

    Time frame: 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.

    Mean duration of anesthetic effect

  3. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: from randomization through study completion (up to 4 days following treatment)

    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).

  4. Number of Participants With a Change in Biomicroscopy

    Time frame: change from baseline through end of study at Day 5

    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.

  5. Mean Change in Visual Acuity

    Time frame: change from baseline through end of study at Day 5

    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).

Sponsors and collaborators

Lead sponsor

American Genomics, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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