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

A Phase 4, Multisite, Randomized, Double-Masked, Well-Controlled 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: The QUELL Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Harrow Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, randomized, double-masked, controlled Phase 4 clinical trial evaluating the non-inferiority of chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) compared with routine anesthesia (topical proparacaine 0.5% plus subconjunctival lidocaine 2%) for ocular surface anesthesia during intravitreal injection (IVT). Adults scheduled to undergo unilateral intravitreal injection of an FDA-approved anti-vascular endothelial growth factor (anti-VEGF) agent for neovascular age-related macular degeneration, diabetic macular edema, retinal vein occlusion, or diabetic retinopathy will be randomized 1:1 to receive either IHEEZO with a sham subconjunctival procedure or routine anesthesia. Randomization will be stratified by clinical site and baseline ocular dryness severity (Standard Patient Evaluation of Eye Dryness \[SPEED\] score). Participants in the experimental arm will receive three topical drops of chloroprocaine ophthalmic gel 3% followed by a sham subconjunctival procedure. Participants in the comparator arm will receive three topical drops of proparacaine 0.5% followed by subconjunctival lidocaine 2%. Standard antiseptic preparation with 5% povidone-iodine will be performed prior to IVT in both arms. The primary endpoint is the proportion of participants achieving successful ocular surface anesthesia, defined as a pain score of 0 or 1 on a 0-5 ordinal pain scale both immediately before and immediately after IVT. Participants requiring rescue anesthesia prior to or during IVT will be considered treatment failures. Secondary endpoints include individual and cumulative pain scores, change from baseline in SPEED questionnaire score, and ocular safety assessments including best-corrected visual acuity, intraocular pressure, corneal fluorescein staining (Oxford scale), and treatment-emergent adverse events through Day 7 (±2 days). Participants will be followed for approximately 7 days after injection.

Conditions

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

Interventions

Type	Name	Description
DRUG	Chloroprocaine Ophthalmic Gel 3% (IHEEZO)	Preservative-free chloroprocaine hydrochloride ophthalmic gel 3% administered as 3 topical drops to the study eye prior to intravitreal injection.
PROCEDURE	Sham Subconjunctival Injection	Sham procedure performed using a syringe with a blunt-tipped cannula that does not contact the conjunctiva, performed to maintain masking prior to intravitreal injection.
DRUG	Proparacaine Hydrochloride Ophthalmic Solution 0.5%	Topical proparacaine hydrochloride ophthalmic solution 0.5% administered as 3 drops to the study eye prior to intravitreal injection.
DRUG	Lidocaine Hydrochloride Injection 2%	Subconjunctival injection of lidocaine hydrochloride 2% administered after topical proparacaine and prior to intravitreal injection.

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-03-09
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study