Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet®.
Ther Deliv
; 14(2): 93-103, 2023 02.
Article
em En
| MEDLINE
| ID: mdl-37158245
Pupil dilation efficacy and efficiency were evaluated using microdosing via the Optejet®. The Optejet® is a new ophthalmologic drug device that utilizes piezoelectric technology to deliver a fine, controlled, horizontal microdroplet spray with precise volume (â¼8 µl), spray pattern and velocity. A single spray versus two sprays of tropicamide-phenylephrine fixed combination (TR-PH FC) were administered to both eyes anesthetic free. Efficacy and safety were evaluated at specific time intervals. The primary end point was the mean change in pupil diameter at 35 min compared with baseline. At 35 min, clinically relevant dilation was observed, with a mean change of 4.55 mm ± 0.68 for one spray and 4.88 ± 0.60 for two sprays. The treatment group difference of one spray of TR-PH FC was noninferior to two sprays (p < 0.001). Rapid dilation was observed at 15 min, and the proportions of eyes that achieved a pupil diameter of ≥6.0 mm were 74% and 83% of patients at 15 min with one spray and two sprays, respectively. The mydriatic agent was well tolerated with the delivery system even in the absence of topical anesthetic, with no ocular or system adverse events reported. Mydriasis is a vital component of routine eye healthcare, and the current standard-of-care mydriatic eye drops potentially have limitations, including contamination, spillage and burning/stinging. Delivery of a mydriatic with the Optejet® may improve patient care flow in the clinical office setting.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pupila
/
Midriáticos
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Revista:
Ther Deliv
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
México
País de publicação:
Reino Unido