Phase 3
Completed N=120
A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution
Anesthesia, Local
Source: ClinicalTrials.gov NCT04829344 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes — 50; 11; 10; 49 Participants
◆ Published Evidence
Emerging
2citations · ~1 / year
Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution.
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.
Linked Publications
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Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.