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
Verified date | May 2022 |
Source | American Genomics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | American Genomics Site 2 | McAllen | Texas |
Lead Sponsor | Collaborator |
---|---|
American Genomics, LLC |
United States,
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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