Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012

Hwang, Jenny; Hwang, Thomas J.; Ciolino, Joseph B.
June 2015
BMJ Open;Jun2015, Vol. 5 Issue 6, p1
Academic Journal
No abstract available.


Related Articles

  • Characteristics of Pivotal Trials and FDA Review of Innovative Devices. Rising, Joshua P.; Moscovitch, Ben // PLoS ONE;Feb2015, Vol. 10 Issue 2, p1 

    When patients lack sufficient treatment options for serious medical conditions, they rely on the prompt approval and development of new therapeutic alternatives, such as medical devices. Understanding the development of innovative medical devices, including the characteristics of premarket...

  • FDA panel favorably votes for ReSure Sealant.  // Ophthalmology Times;10/1/2013, Vol. 38 Issue 19, p20 

    The article reports that the U.S. Food and Drug Administration's (FDA) ophthalmic devices panel has declared ReSure Sealant safe and effective in managing clear corneal wound leaks after cataract surgery based on data from a controlled clinical trial of the medical device.

  • Are we pharmacovigilant enough in ophthalmic practice? Dubey, Ashok; Handu, Shailendra S. // Indian Journal of Ophthalmology;May2013, Vol. 61 Issue 5, p226 

    No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects...

  • Product Briefs.  // Medical Device Daily;2/8/2012, Vol. 16 Issue 26, p10 

    This section offers news briefs on the U.S. medical device industry. Boston Scientific reported positive results from three studies of the WallFlex enteral stent systems. Ethicon Endo-Surgery launched a solution for laparoscopic sleeve gastrectomy designed to help minimize leaks. Ocular...

  • PRODUCT BRIEFS.  // Medical Device Daily;1/8/2009, Vol. 13 Issue 4, p11 

    This section presents an update on issues related to medical devices and instruments in the U.S. Cyberonics filed a proposal to the Food and Drug Administration (FDA) to amend the protocol of its post-market dosing study in depressed patients undergoing VNS Therapy. FDA granted a second...

  • Loteprednol delivers pain relief. Krader, Cheryl Guttman; Comstock, Timothy L. // Optometry Times;Jul/Aug2011, Vol. 3 Issue 7, p28 

    The article discusses studies which showed that loteprednol etabonate (LE) ophthalmic suspension 0.5% provides significant relief of postoperative pain and other symptoms. Optometrist Timothy L. Comstock cites the efficacy of the formulation, which Bausch + Lomb markets as Lotemax, for treating...

  • Product Briefs.  // Medical Device Daily;5/21/2012, Vol. 16 Issue 96, p11 

    This section offers news briefs on the U.S. medical device sector. Clearance from the Food and Drug Administration (FDA) was received by Bioptigen for its Envisu Spectral Domain Ophthalmic Imaging System. A second clinical trial was initiated by NanoString Technologies for its PAM50-based breast...

  • observational study, observational trial.  // Taber's Cyclopedic Medical Dictionary (2009);2009, Issue 21, p1616 

    A definition of the medical term "observational study, observational trial," which refers to a research study that obtains retrospective results, is presented.

  • Considerations for Medical Device Trials. Blake-Michaels, Molly // Applied Clinical Trials;Aug2010, Vol. 19 Issue 8, p32 

    The article focuses on medical devices trials in the U.S. It highlights the operational and regulatory differences between medical device development and drug development. It identifies the unique aspects of clinical studies involving medical devices and it emphasizes the best practice for...

  • Theorem Clinical Research Launches New Branding.  // Biomedical Market Newsletter;6/25/2012, Vol. 21, p1 

    The article focuses on the Think Theorem, a new tagline of the company Theorem Clinical Research launched for enhancing and incorporating the company's vision and mission. Information on the work of Theorem Clinical Research is presented which includes simplifying complex clinical trials,...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics