Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine … (NCT07456826) | Clinical Trial Compass
By InvitationPhase 4
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
United States236 participantsStarted 2026-03-31
Plain-language summary
This Phase 4, multicenter, randomized, double-masked clinical study evaluates the efficacy and safety of chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) compared with routine anesthesia (topical proparacaine 0.5% combined with subconjunctival lidocaine 2%) for ocular surface anesthesia during intravitreal injection procedures. Adult participants scheduled to undergo unilateral intravitreal injection of an FDA-approved anti-vascular endothelial growth factor (anti-VEGF) agent for retinal conditions will be randomized in a 1:1 ratio to receive either IHEEZO with a sham subconjunctival procedure or routine anesthesia.
The primary objective is to determine whether IHEEZO is non-inferior to routine anesthesia in achieving successful ocular surface anesthesia, defined as a participant-reported pain score of 0 or 1 (on a 0-5 ordinal pain scale) immediately before and immediately after intravitreal injection. Secondary outcomes include individual and cumulative pain scores, change from baseline in dry eye symptoms measured by the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and ocular safety assessments through Day 7 follow-up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 investiga…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Achieving Successful Ocular Surface Anesthesia
Timeframe: Immediately before and immediately after intravitreal injection (Day 1)