Anesthesia, Local, Antiseptic
Conditions
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.
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.
Interventions
DRUGChloroprocaine ophthalmic gel 3%
FDA approved topical ophthalmic anesthetic applied 3 drops to the ocular surface before the planned procedure.
Sponsors
Harrow Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients over age 18. * Able to comprehend and sign a statement of informed consent.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed