Phase 3
N=120
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Anesthesia, Local
Bottom Line
View on ClinicalTrials.gov: NCT04829344 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes — 50; 11; 10; 49 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AG-920 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Genomics, LLC
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes |
50; 11; 10; 49 | — |
| SECONDARY How Long it Takes One Dose of AG-920 to Anesthetize the Eye |
0.43; 1.0 | — |
| SECONDARY How Long One Dose of AG-920 Anesthetizes the Eye |
12.78; 6.61 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
10; 4 | — |
| SECONDARY Number of Participants With a Change in Biomicroscopy |
0; 0; 0; 0 | — |
| SECONDARY Change in Visual Acuity |
-0.03; -0.02; -0.01; -0.02 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04829344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.