{"type":"trials","record":{"id":41574,"source_id":"clinicaltrials-gov","external_id":"NCT07456826","title":"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","brief_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.","overall_status":"Enrolling By Invitation","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Harrow Inc","enrollment":236,"countries":["United States"],"start_date":"2026-03-31","completion_date":"2026-08-01","last_update_date":"2026-04-07","source_url":"https://clinicaltrials.gov/study/NCT07456826","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Enrolling By Invitation. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"Quell","age_range":"18 Years","comparator":"Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine)","organization":"Harrow Inc","interventions":["Chloroprocaine Ophthalmic Gel 3% (IHEEZO)","Sham Subconjunctival Injection","Proparacaine Hydrochloride Ophthalmic Solution 0.5%","Lidocaine Hydrochloride Injection 2%"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Proportion of Participants Achieving Successful Ocular Surface Anesthesia — Immediately before and immediately after in…","Pain Score Immediately Before Intravitreal Injection — Immediately before intravitreal injection (Day 1)","Pain Score Immediately After Intravitreal Injection — Immediately after intravitreal injection (Day 1)","Pain Score at Evening Follow-Up — Evening of Day 1 (3-12 hours post-injection)","Pain Score at 24 Hours Post-Injection — Day 2 (20-28 hours post-injection)","Cumulative 24-Hour Pain Score — Day 1 through 24 hours post-injection","Change From Baseline in SPEED Questionnaire Score — Baseline, Evening Day 1, and Day 2 (20-28 hours)","Change in Best-Corrected Visual Acuity — Time Frame: Baseline and Day 7 ± 2 days","Change in Intraocular Pressure — Time Frame: Baseline and Day 7 ± 2 days","Corneal Fluorescein Staining Score — Time Frame: Baseline, post-injection Day 1, and Day 7 ± 2 days","Incidence of Treatment-Emergent Adverse Events — Time Frame: Day 1 through Day 7 ± 2 days Unit: Number of participants…"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · DOUBLE","source_has_results":false},"controlled_terms":["Diabetic Macular Edema (DME)","Age-Related Macular Degeneration (AMD)","Retinal Vein Occlusion","Diabetic Retinopathy (DR)","Chloroprocaine Ophthalmic Gel 3% (IHEEZO)","Sham Subconjunctival Injection","Proparacaine Hydrochloride Ophthalmic Solution 0.5%","Lidocaine Hydrochloride Injection 2%"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct07456826","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-03-31 to 2026-08-01","comparator":"Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine)","confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.836Z","intervention":["Chloroprocaine Ophthalmic Gel 3% (IHEEZO)","Sham Subconjunctival Injection","Proparacaine Hydrochloride Ophthalmic Solution 0.5%","Lidocaine Hydrochloride Injection 2%"],"participants":236,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Proportion of Participants Achieving Successful Ocular Surface Anesthesia — Immediately before and immediately after in…","Pain Score Immediately Before Intravitreal Injection — Immediately before intravitreal injection (Day 1)","Pain Score Immediately After Intravitreal Injection — Immediately after intravitreal injection (Day 1)","Pain Score at Evening Follow-Up — Evening of Day 1 (3-12 hours post-injection)","Pain Score at 24 Hours Post-Injection — Day 2 (20-28 hours post-injection)","Cumulative 24-Hour Pain Score — Day 1 through 24 hours post-injection","Change From Baseline in SPEED Questionnaire Score — Baseline, Evening Day 1, and Day 2 (20-28 hours)","Change in Best-Corrected Visual Acuity — Time Frame: Baseline and Day 7 ± 2 days","Change in Intraocular Pressure — Time Frame: Baseline and Day 7 ± 2 days","Corneal Fluorescein Staining Score — Time Frame: Baseline, post-injection Day 1, and Day 7 ± 2 days","Incidence of Treatment-Emergent Adverse Events — Time Frame: Day 1 through Day 7 ± 2 days Unit: Number of participants…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41574","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}