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    Topical ENaC blocker serves as novel approach to tear film

    First-in-human trial encouraging, identifies agent that is associated with signs of improvement in tear function

     

    Study results

    The P-321 ophthalmic solution showed excellent safety and tolerability, with no discomfort or irritation seen upon instillation of the drug, Dr. Boyer noted. There were no significant changes in corneal and conjunctival staining, visual acuity, biomicroscopy, funduscopy, intraocular pressure, plasma/serum potassium, aldosterone, electrocardiography, or laboratory measurements.

    The adverse events seen in the patients assigned to P-321 were generally similar to or fewer than those that occurred in the patients assigned to placebo, and none of the adverse events was considered serious.

    Related: Exploring link between sleep habits, dry eye

    No subjects left the study as a result of an adverse event. Specifically, nine ocular drug-related events developed in seven patients, all of which were considered to be mild. Two cases of mild conjunctival hyperemia developed, one in a patient assigned to P-321 and one in a patient assigned to placebo.

    The drug was not detected in the patient plasma or urine samples, suggesting that P-321 is not systemically available, Dr. Boyer noted.

    Analysis

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