AntisepticPhase 4NCT05934253
The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine
A Phase 4 study testing Chloroprocaine ophthalmic gel 3% in people with Antiseptic and Anesthesia, Local, run by Harrow Inc at 1 site in United States.
Trial summary
To evaluate if Iheezo's (chloroprocaine 3%) gel vehicle acts as a barrier on the ocular surface, potentially blocking the bactericidal action of povidone-iodine. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Antiseptic, Anesthesia, Local
- What is being tested?
- Chloroprocaine ophthalmic gel 3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 15 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over age 18.
- Able to comprehend and sign a statement of informed consent.
Who cannot join
- Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- Clinically significant ocular trauma.
- Diagnosis of lagophthalmos, or other severe eyelid abnormalities (entropion, ectropion, tumor, edema, blepharospasm, severe trichiasis, severe ptosis.)
- Active ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
- Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
- Ocular infection within the last 3 months.
Show all 9Show fewer
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
- Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
- Monocular patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine: A Comparison vs Tetracaine 0.5% Solution.
To evaluate if Iheezo's (chloroprocaine 3%) gel vehicle acts as a barrier on the ocular surface, potentially blocking the bactericidal action of povidone-iodine.
Read the detailed description
Choice in vehicle plays a large role in drug delivery with topical ophthalmic medications. One strategy to increase efficacy is by increasing the ocular surface contact time of a drug on the eye, primarily by increasing the viscosity of the vehicle. However, studies have demonstrated that high viscosity topical medications act as a barrier to subsequent drops. This poses a serious issue in pre-operative prophylaxis, as high viscosity vehicles may block the bactericidal action of povidone-iodine. This has been supported by in vitro studies of Akten (lidocaine 3.5%) gel.
Akten gel has a viscosity between 4000-9000 cps. Iheezo has a viscosity between 1200-2000 cps. Generic tetracaine 0.5% has a viscosity between 15-25cps. Healthy human tears have a viscosity of around 8 cps. For a vehicle to not act as a barrier to subsequent drops, it is believed that the viscosity should be close to human tears.
This study theorizes that Iheezo's lower viscosity will not act as a barrier to the bactericidal action of Povidone-iodine 5%.
This is a single site, prospective, randomized, patient masked, open-label study evaluating the effects of Iheezo (chloroprocaine HCl ophthalmic gel 3%) and how it may interact with povidone-iodine compared to tetracaine 0.5% ophthalmic solution. Consented patients will have their eyes randomized, one receiving Iheezo and the other tetracaine 0.5% ophthalmic solution.
- Conditions
- Antiseptic, Anesthesia, Local
- Being tested
- Chloroprocaine ophthalmic gel 3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chloroprocaine ophthalmic gel 3%Drug
Also called Iheezo
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine ophthalmic gel 3% | Experimental | FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. Receives: Drug: Chloroprocaine ophthalmic gel 3% |
| Tetracaine ophthalmic solution 0.5% | Active comparator | FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. Receives: Drug: Chloroprocaine ophthalmic gel 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in colony forming units
Comparison of results from Bacterial Culture Swabs before and after application of drug and povidone-iodine. First bacterial culture at initiation. Study medication applied after culture. Povidone-iodine applied two minutes after. Second bacterial culture three minutes after.
Measured: Baseline and 5 minutes after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Jul 2023
- Primary completion15 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntisepticStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harrow Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934253
- Sponsor's protocol ID
- IZ-4-001
- Status last verified
- Sep 2023
- First submitted
- 9 Jun 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine: A Comparison vs Tetracaine 0.5% Solution.
- ClinicalTrials.gov ID
- NCT05934253
- Acronym / sponsor ID
- IZ-4-001
- Conditions
- Antiseptic, Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Harrow IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 6 Jul 2023 (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.
To evaluate if Iheezo's (chloroprocaine 3%) gel vehicle acts as a barrier on the ocular surface, potentially blocking the bactericidal action of povidone-iodine.
Detailed description
Choice in vehicle plays a large role in drug delivery with topical ophthalmic medications. One strategy to increase efficacy is by increasing the ocular surface contact time of a drug on the eye, primarily by increasing the viscosity of the vehicle. However, studies have demonstrated that high viscosity topical medications act as a barrier to subsequent drops. This poses a serious issue in pre-operative prophylaxis, as high viscosity vehicles may block the bactericidal action of povidone-iodine. This has been supported by in vitro studies of Akten (lidocaine 3.5%) gel.
Akten gel has a viscosity between 4000-9000 cps. Iheezo has a viscosity between 1200-2000 cps. Generic tetracaine 0.5% has a viscosity between 15-25cps. Healthy human tears have a viscosity of around 8 cps. For a vehicle to not act as a barrier to subsequent drops, it is believed that the viscosity should be close to human tears.
This study theorizes that Iheezo's lower viscosity will not act as a barrier to the bactericidal action of Povidone-iodine 5%.
This is a single site, prospective, randomized, patient masked, open-label study evaluating the effects of Iheezo (chloroprocaine HCl ophthalmic gel 3%) and how it may interact with povidone-iodine compared to tetracaine 0.5% ophthalmic solution. Consented patients will have their eyes randomized, one receiving Iheezo and the other tetracaine 0.5% ophthalmic solution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine ophthalmic gel 3% | Experimental | Drug: Chloroprocaine ophthalmic gel 3%FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. |
| Tetracaine ophthalmic solution 0.5% | Active comparator | Drug: Chloroprocaine ophthalmic gel 3%FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over age 18.
- Able to comprehend and sign a statement of informed consent.
Key exclusion criteria (9 listed)
- Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- Clinically significant ocular trauma.
- Diagnosis of lagophthalmos, or other severe eyelid abnormalities (entropion, ectropion, tumor, edema, blepharospasm, severe trichiasis, severe ptosis.)
- Active ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
- Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
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%Also: IheezoFDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. | Drug | Chloroprocaine ophthalmic gel 3%, Tetracaine ophthalmic solution 0.5% |
Primary outcome
Change in colony forming units
Time frame: Baseline and 5 minutes after baseline.
Comparison of results from Bacterial Culture Swabs before and after application of drug and povidone-iodine. First bacterial culture at initiation. Study medication applied after culture. Povidone-iodine applied two minutes after. Second bacterial culture three minutes after.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Antiseptic
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Active, not recruitingPhase 4
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Active, not recruitingPhase 2
Ulcer Plants: Highly Accessible Plant Antiseptics for Use in Remote Areas of PNG - Second Trial
Cutaneous Ulcer Disease, Skin Sores
Recruiting
Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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% in people with Antiseptic and Anesthesia, Local, 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 16 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in colony forming units (time frame: Baseline and 5 minutes after baseline.). 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 16 Sep 2025.