Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: A randomized clinical trial

Plager, David A.; Whitson, Jess T.; Netland, Peter A.; Vijaya, Lingam; Sathyan, Parthasarathy; Sood, Devindra; Krishnadas, Subbaiah Ramasamy; Robin, Alan L.; Gross, Robert D.; Scheib, Sally A.; Scott, Haydn; Dickerson, Jaime E.

doi:10.1016/j.jaapos.2009.04.017

Cited by 32 publications

(14 citation statements)

References 14 publications

(25 reference statements)

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“…The Food and Drug Administration approved timolol maleate 0.25% and 0.5% solution or GFS for ophthalmic administration in 2007 for use in children younger than 6 years old with glaucoma. Safety was demonstrated in children using 1 drop per affected eye daily . There have been several publications describing the safety of topical timolol for the treatment of IH, but few were subjected to the typical stringency of a phase 2 clinical trial.…”

mentioning

confidence: 99%

Comment on “Doing the math: A simple approach to topical timolol dosing for infantile hemangiomas”

Hill

Stefanko

Drolet

2018

Pediatric Dermatology

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mentioning

confidence: 99%

Comment on “Doing the math: A simple approach to topical timolol dosing for infantile hemangiomas”

Hill

Stefanko

Drolet

2018

Pediatric Dermatology

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“…The low proportion of patients that achieve IOP control only with topical medications (20%), reflects the aggressive nature of the disease in this age group, suggesting that they are an auxiliary component of the treatment of pediatric glaucoma. Beta-blockers 16,17 , carbonic anhydrase inhibitors, both topical and systemic, 18 and prostaglandin analogs, are an important part of medical treatment in pediatric patients with glaucoma 19 .…”

Section: Discussionmentioning

confidence: 99%

Pediatric glaucomas: clinical features and treatment in a tertiary referral hospital in Mexico City

Güérnez-Graniel¹,

Navarro-Peña²,

Ramírez‐Ortiz³

2019

RMOE

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Pediatric glaucomas are a heterogenous group of eye diseases associated in some cases to genetic syndromes. The objective of this study is to identify the different etiologies of glaucoma in children and to describe medical and surgical treatments in these patients in a tertiary referral hospital. Patients and Methods: Retrospective, descriptive and transversal study. Medical records analysis of patients diagnosed with glaucoma from 2011 to 2015. Age at diagnosis, laterality, etiology, associated syndromes, medical and surgical treatment and follow-up were gathered. Results: We identified 77 patients. Average age at diagnosis was 2.27 years.There was no gender predilection.The most frequent etiology was primary congenital glaucoma (63%) followed by glaucoma secondary to cataract surgery (19%). Sixty percent of all cases were bilateral. All patients underwent examination under anesthesia. Sixty-two patients (80%) required surgical treatment. There were 15 systemic and genetic diseases associated with pediatric glaucoma. Only two thirds of all patients continued their follow-up. Conclusions: Pediatric glaucomas are a challenge for ophthalmologists because they comprise a complex group of eye diseases with a difficult clinical approach due to systemic and genetic abnormalities, delayed diagnosis and high frequency of surgical treatment along with lack of follow-up.

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“…The pediatric indication for pilocarpine was approved in 2010 based on the reported evidence from more than two adequate and controlled prospective efficacy studies in the pediatric population. [17][18][19] This would fit in the No Extrapolation category. However, given that the course and pathophysiology of intraocular hypertension and the treatment effect are currently considered sufficiently similar in adults and pediatric patients, [17][18][19][20][21] it would be reasonable to take a future approach of Complete Extrapolation of efficacy for the pediatric indication, if it is proven efficacious in adults and safe to use in pediatric patients.…”

Section: Impact Of Evolving Science and Knowledge On The Changes In Tmentioning

confidence: 99%

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

Sun

Temeck

Chambers

et al. 2018

Ther Innov Regul Sci

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Background “Complete Extrapolation” of efficacy from adult or other pediatric data, to the pediatric population, is an important scientific tool that reduces the need for pediatric efficacy trials. Dose finding and safety studies in pediatrics are still needed. “No Extrapolation” requires 2 pediatric efficacy trials. “Partial Extrapolation” eliminates the need to conduct 2 pediatric efficacy trials; 1 efficacy or exposure/response study may be sufficient. We examined pediatric extrapolation from 2009 to 2014 evaluating any changes in extrapolation assumptions and the causes for these changes since a prior analysis published in 2011. Methods We reviewed all 157 products with 388 pediatric studies submitted to the FDA from 2009 through 2014. We assessed whether efficacy was extrapolated from adult or other pediatric data and categorized extrapolation as Complete, Partial, or No, and identified the reasons for the changes. Results Partial extrapolation decreased, whereas use of No and Complete extrapolation noticeably increased. Complete, Partial, or No extrapolations changed from 14%, 68%, and 18% in the 2011 study to 34%, 29%, and 37% respectively in the current study. The changes were mostly due to a better understanding of pediatric pathophysiology, why trials have failed, and improved endpoints. Conclusions Evolving science and data obtained from clinical trials increases the certainty of extrapolation assumptions and drives decisions to utilize extrapolation. Lessons learned from the conduct of these trials are critical to improving evidence-based medicine. Extrapolation of Efficacy is a powerful scientific tool that streamlines pediatric product development. Increased knowledge and evolving science inform utilization of this tool.

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Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: A randomized clinical trial

Cited by 32 publications

References 14 publications

Comment on “Doing the math: A simple approach to topical timolol dosing for infantile hemangiomas”

Comment on “Doing the math: A simple approach to topical timolol dosing for infantile hemangiomas”

Pediatric glaucomas: clinical features and treatment in a tertiary referral hospital in Mexico City

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

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