التفاصيل البيبلوغرافية
| العنوان: |
Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution. |
| المؤلفون: |
Gonzalez, Victor H, Wirta, David L, Uram, Martin, Schupp, Audrey, Widmann, Michelle, Novack, Gary D |
| المصدر: |
Clinical Ophthalmology; May2023, Vol. 17, p1357-1365, 9p |
| مصطلحات موضوعية: |
OPHTHALMIC drugs, LOCAL anesthetics, LOCAL anesthesia, DRY eye syndromes, PAIN measurement, PLACEBOS |
| الشركة/الكيان: |
UNITED States. Food & Drug Administration |
| مستخلص: |
Background: We wanted to develop a new topical ocular anesthetic with good bioavailability in anterior segment tissues. Given concerns about contamination and sterility in multi-dose products, we selected a unit-dose, nonpreserved presentation of AG-920 (articaine ophthalmic solution) in blow-fill-seal containers (similar to currently marketed pharmacological therapies for dry eye disease). Methods: Consistent with US Food and Drug Administration guidance, two pivotal, Phase 3, randomized, placebo-controlled, double-masked, parallel design studies conducted at two US private practices in 240 healthy subjects. A single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 s apart). Subjects underwent a conjunctival pinch procedure and assessment of the pain associated with the pinch. The main outcome measure was the proportion of subjects with rating of "No pain at 5 minutes". Results: AG-920 provided a rapid onset of local anesthesia (less than one minute) with clinically and statistically significantly greater effect in AG-920 (68% and 83%) than placebo (3% and 18% for Study 1 and Study 2, respectively, P< 0.0001). The most frequent adverse event was instillation site pain (27% vs 3%) followed by conjunctival hyperemia (probably related to the pinch, 9% vs 10%) in the AG-920 and placebo groups, respectively. Conclusion: AG-920 was found to be have a rapid onset and useful duration of local anesthesia with no major safety issues, and may be useful for the eye-care professional. Registered with clinicaltrials.gov as NCT04513652 and NCT04829344. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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