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Journal of Ocular Pharmacology and... Jun 2024The safety and efficacy of a novel topical ocular anesthetic (AG-920 sterile ophthalmic solution, 8%) was previously evaluated in adults. For both clinical and... (Randomized Controlled Trial)
Randomized Controlled Trial
The safety and efficacy of a novel topical ocular anesthetic (AG-920 sterile ophthalmic solution, 8%) was previously evaluated in adults. For both clinical and regulatory purposes, this new agent was evaluated in children. This was a Phase 3, randomized, active-controlled, single-masked, parallel-group design study in healthy pediatric subjects performed at a private practice retina clinic in the United States. The safety and anesthetic efficacy of AG-920 was compared with proparacaine hydrochloride ophthalmic solution 0.5% in 60 children undergoing ophthalmic examinations. The primary efficacy endpoint was whether the investigator was able to perform the eye examination. In all subjects in each treatment group, the investigator was able to perform the eye examination without additional local anesthetic. There were no adverse events reported in this study. In both the study eye and fellow eye, there were no notable changes after dosing, and both treatment groups were similar. All external eye exams in all subjects in both treatment groups were normal. In this pediatric population aged 7 months to >11 years, AG-920 was therapeutically equivalent to marketed proparacaine with respect to having an ophthalmic examination performed without needing additional local anesthetic. Further, AG-920 was well tolerated, and there were no clinically significant safety findings.
Topics: Humans; Child; Ophthalmic Solutions; Anesthetics, Local; Female; Male; Child, Preschool; Infant; Propoxycaine; Single-Blind Method; Adolescent
PubMed: 38647654
DOI: 10.1089/jop.2023.0187 -
Journal of Ocular Pharmacology and... May 2020
Topics: Anesthetics, Local; Anterior Eye Segment; Cornea; Corneal Diseases; Diagnosis, Differential; Dry Eye Syndromes; Humans; Microscopy, Confocal; Neuralgia; Ophthalmic Solutions; Propoxycaine; Tears
PubMed: 32074469
DOI: 10.1089/jop.2020.29064.res -
European Journal of Ophthalmology Nov 2020We sought to evaluate whether additional topical anesthetic, specifically proparacaine 0.5%, improved patient experience with intravitreal injections without hindering... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
We sought to evaluate whether additional topical anesthetic, specifically proparacaine 0.5%, improved patient experience with intravitreal injections without hindering antisepsis.
METHODS
A prospective, randomized controlled trial was conducted including 36 eyes of 36 patients undergoing intravitreal injections. Patients were randomized to treatment with additional topical proparacaine 0.5% versus control after undergoing informed consent. All patients prior to intravitreal injection underwent conjunctival culture after one drop of topical proparacaine 0.5% was placed. Half of patients then received an additional drop of proparacaine and then underwent a second conjunctival culture. The other half of patients had a drop of povidone iodine and then a second conjunctival culture. Intravitreal injection followed conjunctival cultures. To evaluate their experience, patients were provided with a survey.
RESULTS
In total, 36 patients were enrolled in the study. Three of 36 (8.3%) patients had positive conjunctival cultures after proparacaine eye drops alone. One of 17 (5.8%) patients had a positive conjunctival culture after a second drop of proparacaine. One of 19 (5.3%) patients had a positive culture after proparacaine and povidone iodine. By noninferiority analysis, proparacaine was inferior to povidone iodine ( = .28). Patient experience surveys did not differ between groups.
CONCLUSION
Patient perception did not significantly differ whether or not additional proparacaine drops were used prior to intravitreal injection in a randomized controlled trial. While proparacaine has some antiseptic properties, these were found to be inferior to those of povidone iodine. Therefore, while povidone iodine is essential for antisepsis, additional proparacaine drops should not interfere with antisepsis.
Topics: Aged; Aged, 80 and over; Anesthetics, Local; Endophthalmitis; Eye Infections, Bacterial; Female; Humans; Intravitreal Injections; Male; Middle Aged; Ophthalmic Solutions; Propoxycaine; Prospective Studies
PubMed: 31983237
DOI: 10.1177/1120672120902026