The Effectiveness and Safety of a Novel Crosslinked Hyaluronate Canalicular Gel Occlusive Device for Dry Eye.

PURPOSE: Evaluate effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared to a commercially available hydrogel canalicular plug (Form Fit). SETTING: 5 sites in United States. DESIGN: Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug). METHODS: Adults (≥22 years) with Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral best-corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was non-inferiority of the mean within subject change from baseline to Month 3 in Schirmer score for patients receiving filler compared to plugs. The key secondary effectiveness endpoint was non-inferiority of the proportion of patients with filler achieving improvement from baseline to Month 3 in OSDI by a minimal clinically important difference (MCID). Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear break-up time, and safety. RESULTS: 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was non-inferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI. CONCLUSIONS: Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial keratitis: a retrospective safety surveillance study.

PURPOSE: The objective of this study was to collect and evaluate retrospective safety information about the use of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial keratitis. METHODS: This was a retrospective, postmarketing surveillance study conducted at 10 clinical centers in the United States. The study population included 142 patients treated with besifloxacin ophthalmic suspension 0.6% for bacterial keratitis in one or both eyes. For perspective, data on 85 patients treated at these centers with moxifloxacin ophthalmic solution 0.5% for bacterial keratitis were also included. The analysis was designed to measure the types and rates of adverse events (AEs) reported during the treatment of bacterial keratitis with besifloxacin ophthalmic suspension 0.6%. Other treatment outcomes of interest included the development of corneal scarring and corneal neovascularization, measured or presumed bacterial eradication, ending visual acuity, and duration of pain before and after treatment. RESULTS: There was one reported AE of mild superficial punctate keratitis in a patient using besifloxacin ophthalmic suspension 0.6%. The difference in AE frequencies between groups was not significant (P>0.999). Additional treatment outcomes were similar for both groups. Limitations of this report include the retrospective nature of the study. CONCLUSIONS: These retrospective data suggest that besifloxacin ophthalmic suspension 0.6% was well tolerated when included in the treatment of bacterial keratitis; no serious AEs were reported. A prospective clinical trial is needed to better isolate the contribution of besifloxacin to the therapeutic outcome and to confirm these observations.

Antibiotic resistance in acute postoperative endophthalmitis.

Acute postoperative endophthalmitis (APE) is a serious, although infrequent, complication of eye surgery that can result in significant morbidity and costs. This review addresses APE risk factors, associated bacterial pathogens, antibiotic resistance, and prevention.