Endogenous Endophthalmitis From Methicillin-Resistant Staphylococcus aureus Bacteremia Treated With Ceftaroline.

Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia may lead to endogenous endophthalmitis (EE), an uncommon disease process described mainly in case series and case reports. It is considered an ophthalmologic emergency requiring prompt diagnosis and treatment with systemic intravenous and intravitreal antibiotics to improve mortality and prevent blindness. The management of MRSA EE represents a challenge, as there are no established guidelines for treatment or outcomes. In our case report, we demonstrate that ceftaroline may be considered as an alternative option to treat MRSA EE in lieu of vancomycin due to drug-induced rash, given the promising penetration of the blood brain barrier and low minimum inhibitory concentration (MIC) values for most Staphylococcus aureus isolates.

Use of a Knowledge-Based Governance Approach to Plan a Post-COVID-19 Predoctoral Dental.

COVID-19 abruptly changed dental education, forcing educators out of their comfort zones and into using new technologies and teaching approaches. At the University of Washington School of Dentistry, a task force evaluated the curricular changes that resulted from COVID and made recommendations for the future predoctoral dental curriculum. This manuscript reports the process employed, the findings of the task force, and how these findings will impact the curriculum. A knowledge-based governance (KBG) approach was employed. KBG focuses on gathering all relevant information and identifying all choices. It separates dialogue from deliberation. Information was gathered via literature review, focus group interviews, electronic surveys, and other metrics. The task force evaluated: (1) delivering didactic content remotely; (2) administering assessments remotely; (3) duplicating preclinical simulation lab courses due to social distancing; and (4) the conversion from a numerical to a credit/no credit grading scale. Key recommendations resulted from focus groups and electronic surveys that allowed any student or faculty member an opportunity to provide input. Some topics were relatively non-controversial and strong recommendations were evident. The most controversial issue was which grading scale should be utilized. A KBG approach is an effective means to address mega issues in the dental school environment.

Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery.

PURPOSE: To assess the safety and efficacy of a 0.38% submicron formulation of loteprednol etabonate (LE) gel for the treatment of postoperative inflammation and pain after cataract surgery. SETTING: Forty-five United States ophthalmology practices. DESIGN: Double-masked vehicle-controlled randomized parallel group study. METHODS: Patients 18 years of age or older with anterior chamber cells grade 2 or higher on day 1 after uncomplicated cataract surgery were randomized to 14 days of treatment with LE gel 2 times a day, LE gel 3 times a day, or vehicle. Hierarchical primary endpoints were the proportion of patients with resolution of anterior chamber cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events, intraocular pressure (IOP), biomicroscopy, visual acuity, ophthalmoscopy, and tolerability (drop comfort and ocular symptoms). RESULTS: The intent-to-treat population included 514 patients. Significantly more patients in the LE gel 2 times a day and 3 times a day groups compared with the vehicle group had complete resolution of anterior chamber cells (26.9% and 28.7% versus 9.3%) and reported grade 0 pain (73.7% and 73.1% versus 47.7%) on day 8 (P < .001 vs vehicle for all). The safety findings were unremarkable, with 1 patient experiencing an IOP increase of 10 mm Hg or higher while on LE gel. More than 75% of patients in each group reported no drop discomfort. CONCLUSION: In this study, submicron loteprednol etabonate gel 0.38% appeared safe and effective in the treatment of postoperative inflammation and pain whether instilled 2 times or 3 times a day.

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections.

BACKGROUND: The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of bacterial conjunctivitis infections due to Pseudomonas aeruginosa. METHODS: We undertook a post hoc analysis of clinical outcomes in patients with bacterial conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and bacterial eradication and clinical resolution rates integrated. RESULTS: Of 1317 patients with culture-confirmed bacterial conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity. CONCLUSION: The incidence of bacterial conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.

Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children.

BACKGROUND AND OBJECTIVE: Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with bacterial conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of bacterial conjunctivitis. STUDY DESIGN: This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study. METHODS: A total of 474 patients aged ≥1 year with bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7 ± 1 (visit 3). The co-primary efficacy endpoints were bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed bacterial conjunctivitis. Secondary efficacy endpoints were bacterial eradication and clinical resolution at day 7 ± 1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall bacterial species and individual Gram-positive and Gram-negative bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7 ± 1. RESULTS: Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p < 0.001, and 89/135 [65.9%] vs 62/141 [44.0%], p < 0.001, respectively) at day 4/5. Rates of bacterial eradication continued to be significantly greater in the besifloxacin group (115/135 [85.2%] vs 91/141 [64.5%], respectively; p < 0.001) at day 7 ± 1; however, the rates of clinical resolution did not differ significantly between the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular discharge and bulbar conjunctival injection at each visit were consistent with the primary outcomes. Clinical resolution and bacterial eradication with Gram-positive or Gram-negative organisms were consistent with the overall findings. All AEs in both groups were of mild or moderate severity and were considered unrelated to the treatment. CONCLUSION: Treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and safe in adults and children with bacterial conjunctivitis. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov as NCT00972777.

Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and children.

BACKGROUND: Besifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial conjunctivitis. Pharmacokinetic/pharmacodynamic modeling suggests that besifloxacin might also be effective given twice daily. OBJECTIVE: This study evaluated the efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle (formulation without besifloxacin) in the treatment of adults and children with bacterial conjunctivitis. METHODS: This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study. Patients aged ≥1 year with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or vehicle administered twice daily for 3 days. There were 3 study visits: the baseline visit, visit 2 (day 4 or 5), and visit 3 (day 7±1). Participants recorded the times of medication instillation in a patient diary. The primary end points were clinical resolution and bacterial eradication of the baseline bacterial infection at visit 2 in patients with culture-confirmed bacterial conjunctivitis. Secondary end points were clinical resolution and bacterial eradication of the baseline bacterial infection at visit 3, individual clinical outcomes (ocular conjunctival discharge and bulbar conjunctival injection) at the follow-up visits, and microbial and clinical outcomes for overall bacterial species and individual gram-positive and gram-negative bacterial species. Tolerability assessments included ocular adverse events (AEs), changes in visual acuity, biomicroscopy and ophthalmoscopy findings, and nonocular AEs. RESULTS: Of 202 patients randomized to treatment (mean [SD] age, 25.2 [24.3] years; 56.9% female; 76.7% white), 109 had culture-confirmed bacterial conjunctivitis (53 besifloxacin ophthalmic suspension, 56 vehicle). At visit 2, the besifloxacin ophthalmic suspension group had significantly greater rates of clinical resolution compared with the vehicle group (37/53 [69.8%] vs 21/56 [37.5%], respectively; P < 0.001), as well as significantly greater rates of bacterial eradication (46/53 [86.8%] vs 32/56 [57.1%]; P < 0.001). At visit 3, rates of bacterial eradication were also significantly greater in the besifloxacin ophthalmic suspension group compared with the vehicle group (46/53 [86.8%] vs 39/56 [69.6%]; P = 0.038). Results for the individual clinical outcomes and microbial and clinical outcomes by gram-positive and gram-negative species were consistent with the primary efficacy outcomes. The incidence of ocular AEs did not differ significantly between treatment groups (4/94 [4.3%] vs 8/98 [8.2%]). Ocular AEs in all treated eyes in the respective groups included bacterial conjunctivitis (3/157 [1.9%] and 5/154 [3.2%]), conjunctivitis (3/157 [1.9%] and 4/154 [2.6%]), and allergic conjunctivitis (2/157 [1.3%] and 1/154 [0.6%]). These events were of mild or moderate severity. Changes in visual acuity and biomicroscopy and ophthalmoscopy findings were comparable between groups. There were few nonocular AEs (2/94 [2.1%] vs 3/98 [3.1%]; P = NS), none of them considered treatment related. CONCLUSION: In these adults and children with bacterial conjunctivitis, treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and well tolerated. ClinicalTrials.gov identifier: NCT00972777.

Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis.

OBJECTIVE: To evaluate the clinical efficacy and safety of tobramycin/dexamethasone (TobraDex ST ; 'ST') ophthalmic suspension 0.3%/0.05% compared to azithromycin (Azasite) ophthalmic solution (1%) in the treatment of moderate to severe blepharitis/blepharoconjunctivitis. RESEARCH DESIGN AND METHODS: The study was a multicenter, randomized, investigator-masked, and active-controlled, 15-day study. Enrolled in the study were 122 adult subjects (at least 18 years of age) diagnosed with moderate to severe blepharitis/blepharoconjunctivitis, defined by a minimum score of at least '1' for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye and a minimum global score (total signs and symptoms score) of '5' in the same eye. One group of 61 subjects received ST with instructions to dose 1 drop four times daily (QID) for 14 days. The other group of 61 subjects received azithromycin and dosed with 1 drop twice daily (BID) for 2 days followed by once daily (QD) dosing for 12 days. Visits were conducted at Day 1 (baseline), Day 8 and Day 15. The a priori primary outcome parameter of the study was the seven-item global score defined as the total score of lid margin redness, bulbar conjunctival redness, palpebral conjunctival redness, ocular discharge (0-3 scale), and lid swelling, itchy eyelids, and gritty eyes (0-4 scale). The study utilized standardized, validated photograph control scales developed by Ora, Inc. (Andover, MA). CLINICAL TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov under the registry number NCT01102244. RESULTS: A statistically significant lower mean global score (p = 0.0002) was observed in subjects treated with ST compared to subjects treated with azithromycin at Day 8. No serious adverse events were reported during the course of the study in either group. CONCLUSION: ST provides a fast and effective treatment of acute blepharitis compared to azithromycin. Initial therapy with the combination of tobramycin/dexamethasone provides faster inflammation relief than azithromycin for moderate to severe blepharitis/blepharoconjunctivitis.