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
Public ClinicalTrials.gov record NCT07456826. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07456826
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 236 participants
Conditions and interventions
Conditions
Interventions
- Chloroprocaine Ophthalmic Gel 3% (IHEEZO) Drug
- Sham Subconjunctival Injection Procedure
- Proparacaine Hydrochloride Ophthalmic Solution 0.5% Drug
- Lidocaine Hydrochloride Injection 2% Drug
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2026
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
- Last update posted
- Apr 6, 2026
2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tyler Retina Research Institute | Tyler | Texas | 75703 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07456826, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 6, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07456826 live on ClinicalTrials.gov.