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

Part of paid clinical trials in Tyler, Texas.

Sponsor
Harrow Inc
Study ID
NCT07456826
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chloroprocaine Ophthalmic Gel 3% (IHEEZO) — DRUG
    Preservative-free chloroprocaine hydrochloride ophthalmic gel 3% administered as 3 topical drops to the study eye prior to intravitreal injection.
  • Sham Subconjunctival Injection — PROCEDURE
    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.
  • Proparacaine Hydrochloride Ophthalmic Solution 0.5% — DRUG
    Topical proparacaine hydrochloride ophthalmic solution 0.5% administered as 3 drops to the study eye prior to intravitreal injection.
  • Lidocaine Hydrochloride Injection 2% — DRUG
    Subconjunctival injection of lidocaine hydrochloride 2% administered after topical proparacaine and prior to intravitreal injection.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
236 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: IHEEZO (Chloroprocaine Ophthalmic Gel 3%) + Sham Injection
    Participants receive chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) administered as 3 topical drops to the study eye approximately 1 minute apart prior to intravitreal injection. Approximately 5 minutes after the third drop, a sham subconjunctival injection (using a blunt cannula without conjunctival contact) is performed to maintain masking. Intravitreal injection is then administered per standard of care.
  • Active Comparator: Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine)
    Participants receive proparacaine hydrochloride ophthalmic solution 0.5% administered as 3 topical drops to the study eye approximately 1 minute apart prior to intravitreal injection. This is followed by a subconjunctival injection of lidocaine hydrochloride 2%. Intravitreal injection is then administered per standard of care.

Primary Outcome Measure

Proportion of Participants Achieving Successful Ocular Surface Anesthesia [ Time Frame: Immediately before and immediately after intravitreal injection (Day 1) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tyler Retina Research InstituteTylerTexas75703-

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By research site
Tyler Retina Research Institute· Tyler, TX

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