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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04829344
Other study ID # AG-920-CS302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 30, 2021
Est. completion date May 10, 2021

Study information

Verified date May 2022
Source American Genomics, LLC
Contact n/a
Is FDA regulated No
Health authority
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 May 10, 2021
Est. primary completion date May 6, 2021
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.

Study Design


Related Conditions & MeSH terms


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 2 McAllen Texas

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 proportion 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 To evaluate how long it takes one dose 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 Change in biomicroscopy Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured time point using discrete summary statistics. change from baseline through end of study at Day 5
Secondary 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). change from baseline through end of study at Day 5
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