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NCT07456826

Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections

Enrolling by Invitation
PHASE4Ages 18+InterventionalPrevention
Harrow Inc
~236 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Chloroprocaine Ophthalmic Gel 3% (IHEEZO)Sham Subconjunctival InjectionProparacaine Hydrochloride Ophthalmic Solution 0.5%Lidocaine Hydrochloride Injection 2%

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Achieving Successful Ocular Surface Anesthesia
Measured over Immediately before and immediately after intravitreal injection (Day 1)

Conditions

Diabetic Macular Edema (DME)
Age-Related Macular Degeneration (AMD)
Retinal Vein Occlusion
Diabetic Retinopathy (DR)

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Age-Related Macular DegenerationCystoid Macular EdemaDiabetic RetinopathyMacular edema due to diabetes mellitusRetinal Vein Occlusion

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Samuel Minaker, MD · PRINCIPAL_INVESTIGATOR · Tyler Retina Research Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Able to understand and voluntarily provide written informed consent prior to initiation of any study-specific procedures
Male or female, age ≥ 18 years
Scheduled to undergo unilateral, uncomplicated intravitreal injection of an FDA-approved, non-biosimilar anti-VEGF agent in the study eye
Diagnosis requiring anti-vascular endothelial growth factor (anti-VEGF) treatment, including macular edema (cystoid or diabetic), retinal vein occlusion, diabetic retinopathy, or neovascular age-related macular degeneration
At least three prior intravitreal anti-VEGF injections in the study eye
Fewer than 13 intravitreal anti-VEGF injections in the study eye within the last 365 days
Willing and able to comply with study procedures and follow-up assessments

Exclusion

Scheduled to undergo simultaneous bilateral intravitreal injection
Pre-existing eye pain in the study eye
Fewer than three prior intravitreal anti-VEGF injections in the study eye within 365 days prior to enrollment
Mental disability or cognitive impairment that prevents reliable pain assessment
Prisoner
Pregnant or breastfeeding
Woman of childbearing potential not using an acceptable method of contraception
Inability to comply with study procedures or follow-up assessments
Known sensitivity or allergy to any study medications or related drug classes
History of resistance to local anesthetics
History of Ehlers-Danlos syndrome
Participation in another investigational drug or device study within 30 days prior to screening (unless previously randomized to a control group receiving Eylea, Eylea HD, Lucentis, or Vabysmo)
Use of pain medication, opioids, analgesics, or NSAIDs (any route) within 24 hours prior to Visit 1
Clinically significant systemic disease or condition that, in the Investigator's judgment, may compromise safety or study integrity
Cataract extraction, intraocular surgery, or extraocular surgery within 60 days prior to enrollment that may affect ocular pain
History of autoimmune disease, graft-versus-host disease, fibromyalgia, uveitis, neurotrophic corneal disease, keratitis or corneal ulceration, uncontrolled glaucoma, or herpetic ocular disease
History of endophthalmitis or ocular trauma within 3 months prior to enrollment
Pre-existing subconjunctival hemorrhage or bulbar conjunctival hyperemia
Chronic ocular pain rated moderate to severe within 1 week prior to Visit 1
Active bacterial or viral infection in either eye

What this trial measures

  • Proportion of Participants Achieving Successful Ocular Surface AnesthesiaImmediately before and immediately after intravitreal injection (Day 1)

    Successful ocular surface anesthesia is defined as a participant-reported pain score of 0 (no pain/discomfort) or 1 (pressure only, no pain) at BOTH of the following timepoints: 1. Immediately before intravitreal injection (after subconjunctival or sham injection), and 2. Immediately after intravitreal injection. Pain is assessed using a 0-5 descriptor-based ordinal scale: 0 = No pain/discomfort 1. = Pressure only, no pain 2. = Mild, brief sting/burn; tolerable 3. = Moderate discomfort; tolerable without rescue 4. = Marked pain; difficult to tolerate 5. = Severe/intolerable; procedure cannot continue without rescue Participants requiring rescue anesthesia at any time before or during intravitreal injection are considered treatment failures.