Efficacy and safety of three ophthalmic inserts for topical anaesthesia of the cornea. An exploratory comparative dose-ranging, double-blind, randomized trial in healthy volunteers
| Autor: | Robert Conti, Stéphane Mouly, Saïd El Meski, Guy Simoneau, Alain Gaudric, Yves Tillet, Irène Jarrin, Isabelle Mahé, Jacqueline Otéro, Jean-François Bergmann, Catherine Tavera |
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| Rok vydání: | 2005 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.drug_class Sodium hyaluronate Cataract Extraction Therapeutics Placebo law.invention chemistry.chemical_compound Adjuvants Immunologic Double-Blind Method Randomized controlled trial law Cornea Humans Medicine Pharmacology (medical) Prospective Studies Anesthetics Local Hyaluronic Acid Drug Implants Pharmacology Bupivacaine Cross-Over Studies business.industry Local anesthetic Crossover study Surgery Drug Combinations medicine.anatomical_structure chemistry Anesthesia Concomitant Female business Anesthesia Local medicine.drug |
| Zdroj: | British Journal of Clinical Pharmacology. 59:220-226 |
| ISSN: | 1365-2125 0306-5251 |
| Popis: | Background Cataract surgery requires prolonged anaesthesia, concomitant with permanent hydration and lubrication of the cornea, in order to provide a clear view of the operation area. Aims The primary objective of the study was to assess several formulae of a soluble ophthalmic insert: TOPICSERT [bupivacaine (Bupi) + hyaluronic acid (HA) or sodium hyaluronate] in terms of complete and long-lasting anaesthesia of the cornea. The hydration properties of HA were not assessed in this study. Methods In a prospective double-blind, cross-over, randomized study, with latin-square allocation of treatments, 16 healthy volunteers received a single dose of each formula (A, 1 mg Bupi and 0.1 mg HA; B, 0.5 mg Bupi and 0.1 mg HA; C, 1 mg Bupi and 0 mg HA, and D acting as a placebo) via the ocular route with 1 week of wash-out between each period. Corneal anaesthesia was measured using a Cochet-Bonnet esthesiometer. Results There was a statistically significant difference between treatments with regard to the main criterion (complete anaesthesia lasting at least 20 min) when general association statistics were used (Mantel–Haenzel test, P |
| Databáze: | OpenAIRE |
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