Specific references to clinical studies that provide recognized methods to maximize compliance with NLO and ELC for 5 minutes are summarized. In addition, the current literature is used to formulate the proposed solutions for the problems and obstacles associated with requiring the universal use of NLO and ELC for 5 minutes in all clinical studies of topical glaucoma medications. Reasons for the omission of these important techniques from these clinical studies of efficacy and safety as reflected within the literature are identified and discussed. The potentially undesirable effects of this oversight on the results of clinical studies of topically applied glaucoma medications are described here, with references to the peer-reviewed literature and specific mention of each of the 5 major groups of glaucoma medications. The importance of the universal application of NLO or ELC for 5 minutes following the administration of topical glaucoma medications during all clinical studies to ensure an accurate impression of the efficacy and safety of these medications is emphasized.įollowing a survey of the peer-reviewed literature focused on the clinical benefit from NLO and ELC for 5 minutes, the absence of these simple techniques in published studies of topical glaucoma medications was noted. Several methods to help overcome these difficulties as reflected within the literature are outlined.
In addition, potential obstacles and objections to the inclusion of NLO and ELC for 5 minutes in clinical studies of glaucoma medication are summarized. Furthermore, these government agencies discourage the use of these valuable techniques by the pharmaceutical industry within the studies of the efficacy and safety of glaucoma medications that they sponsor.įollowing a review of the effects of NLO and ELC for 5 minutes on the ocular and systemic absorption of topically applied glaucoma medications, the importance of employing these techniques during clinical studies is summarized. 1 – 9 However, the US Food and Drug Administration (FDA), National Institutes of Health (NIH), and National Eye Institute (NEI) omit these simple techniques from the study of glaucoma medications. The potential clinical benefits of nasolacrimal occlusion (NLO) and eyelid closure (ELC) have been recognized for many years. The undesirable influence on the therapeutic index of each drug influences the safety and efficacy and has implications for the cost of medical treatments, the reproducibility of clinical study results, and dosing regimens, including those of combination therapy, as reflected in the peer-reviewed literature. This omission has major implications for patient informed consent, study protocol consistency, and the value of clinical studies, and directly affects the therapeutic index of glaucoma medications in unpredictable and undesirable ways. Consequently, all glaucoma studies reported in the literature lack the inclusion of these techniques for 5 minutes. The US Food and Drug Administration and the National Institutes of Health discourage the inclusion of these techniques in studies of the efficacy and toxicity of topically applied glaucoma medications. A review of the literature suggests that NLO and ELC improve intraocular penetration of topically applied glaucoma medications and discourage systemic absorption.
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