Evaluating the effects of a new eye gel on infection prevention
The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine: A Comparison vs Tetracaine 0.5% Solution.
This study is testing if a new eye gel can help an antiseptic work better to prevent infections before eye surgery in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Harrow Inc Industry-sponsored |
| Locations | 1 site (Brandon, Florida) |
| Trial ID | NCT05934253 on ClinicalTrials.gov |
What this trial studies
This study investigates whether Iheezo, a low viscosity chloroprocaine ophthalmic gel, can effectively allow the bactericidal action of povidone-iodine to function without interference. It is a single-site, prospective, randomized, patient-masked, open-label study where participants will receive either Iheezo or tetracaine 0.5% ophthalmic solution in their eyes. The goal is to determine if the lower viscosity of Iheezo prevents it from acting as a barrier to the antiseptic properties of povidone-iodine, which is crucial for pre-operative prophylaxis. The study will include patients over 18 who can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who can provide informed consent and do not have recent ocular surgery or significant ocular conditions.
Not a fit: Patients with recent ocular surgery, significant ocular trauma, or active ocular infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enhance infection prevention during ocular procedures by ensuring effective antiseptic action.
How similar studies have performed: While similar studies have explored the effects of viscosity on drug delivery, this specific approach with Iheezo is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brandon, Florida
- Brandon Eye Associates — Brandon, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Richard Costine, PharmD
- Email: rcostine@harrowinc.com
- Phone: 8505097474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.