The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Chloroprocaine ophthalmic gel 3% FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. |
Drug: Chloroprocaine ophthalmic gel 3%
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
Other Names:
|
| Active Comparator: Tetracaine ophthalmic solution 0.5% FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure. |
Drug: Chloroprocaine ophthalmic gel 3%
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in colony forming units [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over age 18.
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Able to comprehend and sign a statement of informed consent.
Exclusion Criteria:
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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.
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Clinically significant ocular trauma.
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Diagnosis of lagophthalmos, or other severe eyelid abnormalities (entropion, ectropion, tumor, edema, blepharospasm, severe trichiasis, severe ptosis.)
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Active ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
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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).
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Ocular infection within the last 3 months.
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Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
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Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
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Monocular patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brandon Eye Associates | Brandon | Florida | United States | 33511 |
Sponsors and Collaborators
- Harrow Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IZ-4-001