skip to main content
Language:
Search Limited to: Search Limited to: Resource type Show Results with: Show Results with: Search type Index

0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects

Clinical ophthalmology (Auckland, N.Z.), 2023-08, Vol.17, p.2219-2230 [Peer Reviewed Journal]

2023 Hosseini et al. ;COPYRIGHT 2023 Dove Medical Press Limited ;2023 Hosseini et al. 2023 Hosseini et al. ;ISSN: 1177-5467 ;ISSN: 1177-5483 ;EISSN: 1177-5483 ;DOI: 10.2147/OPTH.S419857 ;PMID: 37564159

Full text available

Citations Cited by
  • Title:
    0.2% Betamethasone Sodium Phosphate: A Multicenter, Randomized, Double-Masked Study to Compare Its Ocular Safety, Tolerability, and Efficacy to Vehicle in Cataract Surgery Subjects
  • Author: Hosseini, Kamran ; Gollamudi, Subba ; Reiser, Harvey ; Walters, Tom ; Lindstrom, Richard L
  • Subjects: Betamethasone ; betamethasone sodium phosphate ; Cataract ; Clinical Trial Report ; corticosteroid ; Corticosteroids ; Difluprednate ; Inflammation ; Medical research ; Medicine, Experimental ; Patient compliance ; Phosphates ; postoperative inflammation ; preservative-free ; Surfing ; Surgery
  • Is Part Of: Clinical ophthalmology (Auckland, N.Z.), 2023-08, Vol.17, p.2219-2230
  • Description: To compare the preservative-free corticosteroid 0.2% betamethasone sodium phosphate BID (SURF-201) to vehicle BID in patients undergoing routine cataract surgery. Phase 2, multicenter, randomized (1:1 ratio), double-masked, vehicle-controlled, parallel-group study in patients scheduled for uncomplicated cataract surgery without the aid of a femtosecond laser. Subjects instilled topical medications for 16 days beginning the day before cataract surgery (Day -1), 1 dose administered at least 1 hour prior to cataract surgery (on Day 0) and 1 dose on the evening after cataract surgery, and then 2 doses administered each day through Day 15; patients were re-evaluated on Days 22 and 32 to ensure no rebound inflammation. Primary outcome was the difference in the proportion of subjects with anterior chamber cell (ACC) grade 0 between the two groups at Day 15. Secondary outcomes included pain scores and overall safety. There was a statistically significant difference (P=0.004) in the proportion of subjects in the SURF-201 treatment group with an ACC grade of 0 at Day 15 (n=22/39 [56.4%]) compared to subjects in the vehicle treatment group (n=9/43 [20.9%]). There was no statistically significant difference (P=0.528) in the proportion of subjects in the SURF-201 treatment group who had a visual analog scale pain score of 0 at Day 15 (n=35/38 [89.7%]) compared to subjects in the vehicle group (n=33/40 [82.5%]). A slightly higher incidence of adverse events occurred in subjects in the SURF-201 treatment group (n=27/40 [67.5%]) compared to the vehicle treatment group (n=23/43 [53.5%]). SURF-201 is an effective topical, preservative-free corticosteroid when dosed BID for the treatment of postoperative inflammation and prevention of pain in a post-cataract population.
  • Publisher: New Zealand: Dove Medical Press Limited
  • Language: English
  • Identifier: ISSN: 1177-5467
    ISSN: 1177-5483
    EISSN: 1177-5483
    DOI: 10.2147/OPTH.S419857
    PMID: 37564159
  • Source: Open Access: PubMed Central
    Geneva Foundation Free Medical Journals at publisher websites
    AUTh Library subscriptions: ProQuest Central
    DOAJ Directory of Open Access Journals
    Dove Press Free
Back to results list
INSPIRE LIBRARY - TON DUC THANG UNIVERSITY (84-028) 37 755 057 Feedback
19 Nguyen Huu Tho St. Dist.7, HCM thuvien@tdtu.edu.vn

Copyright © 2017 INSPIRE LIBRARY - TON DUC THANG UNIVERSITY

Searching Remote Databases, Please Wait