Diabetic Macular Edema (DME)Phase 4QuellNCT07456826
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 study testing Chloroprocaine Ophthalmic Gel 3% (IHEEZO), Proparacaine Hydrochloride Ophthalmic Solution 0.5% and Lidocaine Hydrochloride Injection 2% in people with Diabetic Macular Edema (DME) and Age-Related Macular Degeneration (AMD), run by Harrow Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME), Age-Related Macular Degeneration (AMD), Retinal Vein Occlusion
- What is being tested?
- Chloroprocaine Ophthalmic Gel 3% (IHEEZO), Proparacaine Hydrochloride Ophthalmic Solution 0.5% and Lidocaine Hydrochloride Injection 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Aug 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily provide written informed consent prior to initiation of any study-specific procedures
- Male or female, age ≥ 18 years
- Scheduled to undergo unilateral, uncomplicated intravitreal injection of an FDA-approved, non-biosimilar anti-VEGF agent in the study eye
- Diagnosis requiring anti-vascular endothelial growth factor (anti-VEGF) treatment, including macular edema (cystoid or diabetic), retinal vein occlusion, diabetic retinopathy, or neovascular age-related macular degeneration
- At least three prior intravitreal anti-VEGF injections in the study eye
- Fewer than 13 intravitreal anti-VEGF injections in the study eye within the last 365 days
- Willing and able to comply with study procedures and follow-up assessments
Who cannot join
- Scheduled to undergo simultaneous bilateral intravitreal injection
- Pre-existing eye pain in the study eye
- Fewer than three prior intravitreal anti-VEGF injections in the study eye within 365 days prior to enrollment
- Mental disability or cognitive impairment that prevents reliable pain assessment
- Prisoner
- Pregnant or breastfeeding
Show all 20Show fewer
- Woman of childbearing potential not using an acceptable method of contraception
- Inability to comply with study procedures or follow-up assessments
- Known sensitivity or allergy to any study medications or related drug classes
- History of resistance to local anesthetics
- History of Ehlers-Danlos syndrome
- Participation in another investigational drug or device study within 30 days prior to screening (unless previously randomized to a control group receiving Eylea, Eylea HD, Lucentis, or Vabysmo)
- Use of pain medication, opioids, analgesics, or NSAIDs (any route) within 24 hours prior to Visit 1
- Clinically significant systemic disease or condition that, in the Investigator's judgment, may compromise safety or study integrity
- Cataract extraction, intraocular surgery, or extraocular surgery within 60 days prior to enrollment that may affect ocular pain
- History of autoimmune disease, graft-versus-host disease, fibromyalgia, uveitis, neurotrophic corneal disease, keratitis or corneal ulceration, uncontrolled glaucoma, or herpetic ocular disease
- History of endophthalmitis or ocular trauma within 3 months prior to enrollment
- Pre-existing subconjunctival hemorrhage or bulbar conjunctival hyperemia
- Chronic ocular pain rated moderate to severe within 1 week prior to Visit 1
- Active bacterial or viral infection in either eye
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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)
- Being tested
- Chloroprocaine Ophthalmic Gel 3% (IHEEZO), Sham Subconjunctival Injection, Proparacaine Hydrochloride Ophthalmic Solution 0.5%, Lidocaine Hydrochloride Injection 2%
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 InjectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| IHEEZO (Chloroprocaine Ophthalmic Gel 3%) + Sham Injection | Experimental | 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. Receives: Drug: Chloroprocaine Ophthalmic Gel 3% (IHEEZO); Procedure: Sham Subconjunctival Injection |
| Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine) | Active comparator | 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. Receives: Drug: Proparacaine Hydrochloride Ophthalmic Solution 0.5%; Drug: Lidocaine Hydrochloride Injection 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Successful Ocular Surface Anesthesia
Successful ocular surface anesthesia is defined as a participant-reported pain score of 0 (no pain/discomfort) or 1 (pressure only, no pain) at BOTH of the following timepoints:
- Immediately before intravitreal injection (after subconjunctival or sham injection), and
- Immediately after intravitreal injection.
Pain is assessed using a 0-5 descriptor-based ordinal scale:
0 = No pain/discomfort
- = Pressure only, no pain
- = Mild, brief sting/burn; tolerable
- = Moderate discomfort; tolerable without rescue
- = Marked pain; difficult to tolerate
- = Severe/intolerable; procedure cannot continue without rescue
Participants requiring rescue anesthesia at any time before or during intravitreal injection are considered treatment failures.
Measured: Immediately before and immediately after intravitreal injection (Day 1)
Secondary outcomes (10)
Pain Score Immediately Before Intravitreal Injection
Pain is assessed using a 0-5 descriptor-based ordinal pain scale (minimum = 0, maximum = 5), where 0 indicates no pain and 5 indicates severe/intolerable pain. Higher scores indicate greater pain intensity.
Measured: Immediately before intravitreal injection (Day 1)
Pain Score Immediately After Intravitreal Injection
Pain is assessed using a 0-5 descriptor-based ordinal pain scale (minimum = 0, maximum = 5), where 0 indicates no pain and 5 indicates severe/intolerable pain. Higher scores indicate greater pain intensity.
Measured: Immediately after intravitreal injection (Day 1)
Pain Score at Evening Follow-Up
Participant-reported pain score assessed 3-12 hours after intravitreal injection. Pain is assessed using a 0-5 descriptor-based ordinal pain scale (minimum = 0, maximum = 5), where 0 indicates no pain and 5 indicates severe/intolerable pain. Higher scores indicate greater pain intensity.
Measured: Evening of Day 1 (3-12 hours post-injection)
Pain Score at 24 Hours Post-Injection
Participant-reported pain score assessed 20-28 hours after intravitreal injection. Pain is assessed using a 0-5 descriptor-based ordinal pain scale (minimum = 0, maximum = 5), where 0 indicates no pain and 5 indicates severe/intolerable pain. Higher scores indicate greater pain intensity.
Measured: Day 2 (20-28 hours post-injection)
Cumulative 24-Hour Pain Score
Sum of four pain assessments: pre-injection, post-injection, evening follow-up, and 24-hour follow-up. Each individual pain score ranges from 0 to 5; therefore, the cumulative 24-hour pain score ranges from 0 to 20. Higher scores indicate greater cumulative pain.
Measured: Day 1 through 24 hours post-injection
Change From Baseline in SPEED Questionnaire Score
Change from baseline in Standard Patient Evaluation of Eye Dryness (SPEED) total score. The SPEED questionnaire total score ranges from 0 to 28, with higher scores indicating greater dry eye symptom severity.
Measured: Baseline, Evening Day 1, and Day 2 (20-28 hours)
Change in Best-Corrected Visual Acuity
Best-corrected visual acuity measured using LogMAR visual acuity scale (minimum and maximum values dependent on chart range). Lower LogMAR values indicate better visual acuity.
Measured: Time Frame: Baseline and Day 7 ± 2 days
Change in Intraocular Pressure
Intraocular pressure measured in millimeters of mercury (mmHg). Higher values indicate higher intraocular pressure.
Measured: Time Frame: Baseline and Day 7 ± 2 days
Corneal Fluorescein Staining Score
Corneal staining graded using the Oxford Grading Scale (ordinal scale, minimum = 0, maximum = 5). Higher grades indicate greater corneal staining severity.
Measured: Time Frame: Baseline, post-injection Day 1, and Day 7 ± 2 days
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: Time Frame: Day 1 through Day 7 ± 2 days Unit: Number of participants with ≥1 TEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start31 Mar 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harrow Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Minaker, MD, Principal investigator, Tyler Retina Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456826
- Sponsor's protocol ID
- IZ-4-002
- Acronym
- Quell
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Harrow does not plan to make de-identified IPD available for secondary research purposes. IPD will not be available for access
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07456826
- Acronym / sponsor ID
- Quell / IZ-4-002
- Conditions
- Diabetic Macular Edema (DME), Age-Related Macular Degeneration (AMD), Retinal Vein Occlusion, Diabetic Retinopathy (DR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Harrow IncIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IHEEZO (Chloroprocaine Ophthalmic Gel 3%) + Sham Injection | Experimental | Drug: Chloroprocaine Ophthalmic Gel 3% (IHEEZO), Procedure: Sham Subconjunctival InjectionParticipants 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. |
| Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine) | Active comparator | Drug: Proparacaine Hydrochloride Ophthalmic Solution 0.5%, Drug: Lidocaine Hydrochloride Injection 2%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to understand and voluntarily provide written informed consent prior to initiation of any study-specific procedures
- Male or female, age ≥ 18 years
- Scheduled to undergo unilateral, uncomplicated intravitreal injection of an FDA-approved, non-biosimilar anti-VEGF agent in the study eye
- Diagnosis requiring anti-vascular endothelial growth factor (anti-VEGF) treatment, including macular edema (cystoid or diabetic), retinal vein occlusion, diabetic retinopathy, or neovascular age-related macular degeneration
- At least three prior intravitreal anti-VEGF injections in the study eye
Key exclusion criteria (20 listed)
- Scheduled to undergo simultaneous bilateral intravitreal injection
- Pre-existing eye pain in the study eye
- Fewer than three prior intravitreal anti-VEGF injections in the study eye within 365 days prior to enrollment
- Mental disability or cognitive impairment that prevents reliable pain assessment
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | IHEEZO (Chloroprocaine Ophthalmic Gel 3%) + Sham Injection |
| Sham Subconjunctival InjectionSham procedure performed using a syringe with a blunt-tipped cannula that does not contact the conjunctiva, performed to maintain masking prior to intravitreal injection. | Procedure or surgery | IHEEZO (Chloroprocaine Ophthalmic Gel 3%) + Sham Injection |
| 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 | Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine) |
| Lidocaine Hydrochloride Injection 2%Subconjunctival injection of lidocaine hydrochloride 2% administered after topical proparacaine and prior to intravitreal injection. | Drug | Routine Anesthesia (Proparacaine + Subconjunctival Lidocaine) |
Primary outcome
Proportion of Participants Achieving Successful Ocular Surface Anesthesia
Time frame: Immediately before and immediately after intravitreal injection (Day 1)
Successful ocular surface anesthesia is defined as a participant-reported pain score of 0 (no pain/discomfort) or 1 (pressure only, no pain) at BOTH of the following timepoints: 1. Immediately before intravitreal injection (after subconjunctival or sham injection), and 2. Immediately after intravitreal injection. Pain is assessed using a 0-5 descriptor-based ordinal scale: 0 = No pain/discomfort 1. = Pressure only, no pain 2. = Mild, brief sting/burn; tolerable 3. = Moderate discomfort; tolerable without rescue 4. = Marked pain; difficult to tolerate 5. = Severe/intolerable; procedure cannot continue without rescue Participants requiring rescue anesthesia at any time before or during intravitreal injection are considered treatment failures.
10 secondary outcomes
Pain Score Immediately Before Intravitreal Injection
Time frame: Immediately before intravitreal injection (Day 1)
Pain Score Immediately After Intravitreal Injection
Time frame: Immediately after intravitreal injection (Day 1)
Pain Score at Evening Follow-Up
Time frame: Evening of Day 1 (3-12 hours post-injection)
Pain Score at 24 Hours Post-Injection
Time frame: Day 2 (20-28 hours post-injection)
Cumulative 24-Hour Pain Score
Time frame: Day 1 through 24 hours post-injection
Change From Baseline in SPEED Questionnaire Score
Time frame: Baseline, Evening Day 1, and Day 2 (20-28 hours)
Change in Best-Corrected Visual Acuity
Time frame: Time Frame: Baseline and Day 7 ± 2 days
Change in Intraocular Pressure
Time frame: Time Frame: Baseline and Day 7 ± 2 days
Corneal Fluorescein Staining Score
Time frame: Time Frame: Baseline, post-injection Day 1, and Day 7 ± 2 days
Incidence of Treatment-Emergent Adverse Events
Time frame: Time Frame: Day 1 through Day 7 ± 2 days Unit: Number of participants with ≥1 TEA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Harrow does not plan to make de-identified IPD available for secondary research purposes. IPD will not be available for access
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Minaker, MD principal investigator
Tyler Retina Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroprocaine Ophthalmic Gel 3% (IHEEZO), Proparacaine Hydrochloride Ophthalmic Solution 0.5% and Lidocaine Hydrochloride Injection 2% in people with Diabetic Macular Edema (DME) and Age-Related Macular Degeneration (AMD), run by Harrow Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Successful Ocular Surface Anesthesia (time frame: Immediately before and immediately after intravitreal injection (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.