The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povid… (NCT05934253) | Clinical Trial Compass
CompletedPhase 4
The Effects of Low Viscosity Chloroprocaine Ophthalmic Gel 3% on the Bactericidal Action of Povidone-Iodine
United States100 participantsStarted 2023-07-15
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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.