A systematic review and meta-analysis to compare the efficacy of acyclovir 3% ophthalmic ointment to idoxuridine in curing herpetic keratitis by Day 7 of treatment.

Background: This objective of the review and analysis is to demonstrate that acyclovir (ACV) 3% ophthalmic ointment is superior to idoxuridine (IDU) in treating herpetic keratitis (HK) presenting as dendritic and geographic ulcer sub-types.

Data Sources: Publications in human subjects were identified by searching the Ovid MEDLINE database through April 2011, combining medical subject headings (MESH) "Keratitis, Herpetic/" AND "Acyclovir/" limiting by the key words "topical" OR "ointment" and also restricted to MESH "Administration, Topical/" OR "Ointments/". The results were cross checked with the references used in the Cochrane Database Syst Rev.

Clinical evaluation of pazopanib eye drops versus ranibizumab intravitreal injections in subjects with neovascular age-related macular degeneration.

Purpose: To evaluate pazopanib eye drops in subjects with active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Design: Multicountry, randomized, parallel-group, double-masked, active and placebo-controlled, dose-ranging study of eye drops.

Participants: A total of 510 subjects (93% white; 58% female; mean age, 75.

Clinical evaluation of pazopanib eye drops in healthy subjects and in subjects with neovascular age-related macular degeneration.

Purpose: To evaluate pazopanib 10 mg/mL eye drops (pazopanib) in healthy subjects and in subjects with previously untreated subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Methods: Study 1 (single center, randomized, placebo-controlled, double-masked) included 3 cohorts of 12 to 13 healthy subjects each who instilled pazopanib or placebo 4 times daily for 2 weeks. Study 2 (multicenter open-label) included 19 subjects with neovascular age-related macular degeneration who instilled pazopanib 4 times daily for 12 weeks.

Predictive models of choroidal neovascularization and geographic atrophy incidence applied to clinical trial design.

Purpose: To develop comprehensive predictive models for choroidal neovascularization (CNV) and geographic atrophy (GA) incidence within 3 years that can be applied realistically to clinical practice.

Design: Retrospective evaluation of data from a longitudinal study to develop and validate predictive models of CNV and GA.

Methods: The predictive performance of clinical, environmental, demographic, and genetic risk factors was explored in regression models, using data from both eyes of 2011 subjects from the Age-Related Eye Disease Study (AREDS).

Coronary heart disease outcomes among chronic opioid and cyclooxygenase-2 users compared with a general population cohort.

Background: We estimated the incidence of myocardial infarction (MI) and coronary revascularization (CR) among users of chronic opioid therapy (COT) and compared risks across categories of morphine-equivalent doses of COT and comparator cohorts.

Methods: We conducted a retrospective claims-based study using de-identified data from a commercially insured population. A cohort of 148,657 adult users of COT, a matched cohort of the general population, and three cohorts of users of chronic cyclooxygenase-2 (COX-2) inhibitor therapy totaling 122,810 were identified.

Epidemiology of opioid pharmacy claims in the United States.

Objective: To describe opioid pharmacy claims patterns in the United States among an insured population.

Design: Information was obtained from the US insurance claims database, IMS Lifelink, between 1997 and 2002. Descriptive statistics of opioid claims patterns were described with stratification by gender, age, and year of use.

Ethical issues, safety, and data integrity in clinical trials.

Published in 1974, the Belmont Report established the ethical principles for conducting clinical research in the United States. The essential concepts are respect for the research participant, beneficence for society at large, and justice (equal access to participation and equal treatment) toward subjects in a research study. These principles are applied through the use of informed consent, risk/benefit assessment, and the impartial selection of study subjects.

Understanding the drug development process.

In the United States, new drug development is a complex, highly regulated process that often involves academic institutions, the pharmaceutical industry, and government agencies. Much of the primary and clinical research conducted in the United States is funded by the National Institutes of Health. The Food and Drug Administration (FDA) provides regulatory review and oversight of the drug development process.