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ENROLLING BY INVITATION
NCT07456826
PHASE4

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

Sponsor: Harrow Inc

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2026-03-31

Completion Date

2026-08

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

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.

Locations (1)

Tyler Retina Research Institute

Tyler, Texas, United States