No ConditionPhase 4NCT07895420
Comparing Intravitreal Injection Pain Scores Using Iheezo (Chloroprocaine Hcl Ophthalmic Gel 3%) Versus Subconjunctival Lidocaine (2%): A Randomized, Controlled Trial
A Phase 4 study testing chloroprocaine HCL 3% and Subconjunctival Lidocaine in people with No Condition, run by Retina Research Institute, LLC at 4 sites in United States.
Trial summary
This will be a prospective, randomized, controlled non-inferiority trial comparing the efficacy of Iheezo versus subconjunctival 2% lidocaine in reducing intravitreal injection pain scores up to 24 hours after injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No Condition
- What is being tested?
- chloroprocaine HCL 3% and Subconjunctival Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Oct 2025to 30 Dec 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
- At least 1 previous intravitreal injection in the last 180 days from screening.
Who cannot join
- History of more than 13 intravitreal injections.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
The Retina Institute
Chesterfield, Missouri, 63017
Research Manager, B.S., 314-367-1181, allan.braverman@rc-stl.com
- Recruiting
The Retina Institute
City of Saint Peters, Missouri, 63376
Research Manager, B.S., 314-367-1181, allan.braverman@rc-stl.com
- Recruiting
The Retina Institute
Glen Carbon, Illinois, 62034
Research Manager, B.S., 314-367-1181, allan.braverman@rc-stl.com
- Recruiting
The Retina Institute
St Louis, Missouri, 63128
Research Manager, B.S., 314-367-1181, allan.braverman@rc-stl.com
Research Director, M.S. Pharm, MBA, 314-367-1181, justin.hyers@rc-stl.com
About this study
This will be a prospective, randomized, controlled non-inferiority trial comparing the efficacy of Iheezo versus subconjunctival 2% lidocaine in reducing intravitreal injection pain scores up to 24 hours after injection.
Read the detailed description
The purpose of this study is to assess and compare patient pain and symptom levels up to 24 hours post-intravitreal injection when using Iheezo (Chloroprocaine HCl ophthalmic gel 3%) versus subconjunctival Lidocaine (2%) for pre-procedure anesthesia. Both medications are approved to be used for pre-procedure anesthesia. Approximately 80 subjects will participate in this study.
- Conditions
- No Condition
- Being tested
- chloroprocaine HCL 3%, Subconjunctival Lidocaine
- Keywords
- Iheezo, pain scores, intravitreal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chloroprocaine HCL 3%Drug
Topical anesthetic for intravitreal injection
Subconjunctival LidocaineDrug
Procedural anesthetic for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Iheezo | Active comparator | Not described Receives: Drug: chloroprocaine HCL 3% |
| Subconjunctival Lidocaine | Active comparator | Not described Receives: Drug: Subconjunctival Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Patient-reported ocular pain 4 hours after intravitreal injection using Visual Analog Pain Score Surveys.
Measured: 4 hourse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start30 Oct 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to assignment in Iheezo vs. subconjunctival lidocaine cohorts
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Research Institute, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Iafe, Retina Research Institute, LLC
- Investigators
- Nicholas Iafe, MD, Principal investigator, The Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895420
- Sponsor's protocol ID
- RetinaRI
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Intravitreal Injection Pain Scores Using Iheezo (Chloroprocaine Hcl Ophthalmic Gel 3%) Versus Subconjunctival Lidocaine (2%): A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07895420
- Acronym / sponsor ID
- RetinaRI
- Conditions
- No Condition
- Keywords
- Iheezo, pain scores, intravitreal injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Retina Research Institute, LLCUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Oct 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 will be a prospective, randomized, controlled non-inferiority trial comparing the efficacy of Iheezo versus subconjunctival 2% lidocaine in reducing intravitreal injection pain scores up to 24 hours after injection.
Detailed description
The purpose of this study is to assess and compare patient pain and symptom levels up to 24 hours post-intravitreal injection when using Iheezo (Chloroprocaine HCl ophthalmic gel 3%) versus subconjunctival Lidocaine (2%) for pre-procedure anesthesia. Both medications are approved to be used for pre-procedure anesthesia. Approximately 80 subjects will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization to assignment in Iheezo vs. subconjunctival lidocaine cohorts
| Arm | Type | Receives |
|---|---|---|
| Iheezo | Active comparator | Drug: chloroprocaine HCL 3% |
| Subconjunctival Lidocaine | Active comparator | Drug: Subconjunctival Lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 1 previous intravitreal injection in the last 180 days from screening.
Key exclusion criteria (1 listed)
- History of more than 13 intravitreal injections.
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 HCL 3%Topical anesthetic for intravitreal injection | Drug | Iheezo |
| Subconjunctival LidocaineProcedural anesthetic for intravitreal injection | Drug | Subconjunctival Lidocaine |
Primary outcome
Pain Scores
Time frame: 4 hourse
Patient-reported ocular pain 4 hours after intravitreal injection using Visual Analog Pain Score Surveys.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Nicholas Iafe, MD principal investigator
The Retina Institute
4 sites 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 HCL 3% and Subconjunctival Lidocaine in people with No Condition, run by Retina Research Institute, LLC at 4 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Allan Braverman, B.S. (314-367-1181 ext. 2614, allan.braverman@rc-stl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 4 hourse). 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 26 Oct 2026.