A Randomized, Controlled Trial Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA).

Purpose: We compare outcomes in eyes with dry eye disease (DED) treated with TearCare (TC) or topical cyclosporine 0.05% (RESTASIS; CsA). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, randomized, assessor-masked, controlled IRB-approved trial. Eligible subjects: ≥22 years of age, dry eye symptoms within 3-6 months, Tear Break-up Time (TBUT) ≥1 to ≤7 s, Meibomian Gland Secretion Score (MGSS) ≤12, Ocular Surface Disease Index (OSDI) of 23-79. Randomized (1:1) to TC or CsA. TC subjects treated at baseline and month 5; CsA was twice daily for 6 months. Methods: Follow-up visits were scheduled for Day 1, Week 1, Months 1, 3, and 6 with primary inference at Month 6. Primary outcomes: TBUT and OSDI; secondary outcomes: MGSS, conjunctival and corneal staining, eye dryness score (EDS), symptoms assessment in dry eye (SANDE) score, and Schirmer tear score (STS). Safety assessments included adverse events, best corrected visual acuity, intraocular pressure, and slit-lamp findings. Results: Overall, 345 subjects, 172 TC and 173 CsA. TBUT improved at all time points in both groups (p<0.0001), with statistically greater improvement for TC versus CsA (p=0.0006). OSDI improved significantly at all time points in both groups (p<0.0001) with no significant differences between treatments. MGSS and other measures of meibomian gland function improved significantly more with TC eyes versus CsA; other secondary outcomes showed significant improvements in both groups with no difference between groups. Treatment-related adverse events were uncommon (10 total, 8 in the CsA group consistent with prior CsA studies); most (9/10) mild. Conclusion: TC provides statistically superior and sustained improvement in TBUT and multiple measures of meibomian gland secretion, and non-inferior improvement in OSDI, corneal and conjunctival staining, SANDE, EDS, and STS versus CsA. TC should be a preferred treatment for DED associated with MGD.

A Prospective Study of Cyclosporine A 0.1% Combined with Loteprednol 0.2% vs Cyclosporine A 0.05% Alone in the Treatment of Dry Eye.

Purpose: To examine the efficacy and tolerability of a combination of cyclosporine 0.1% and loteprednol 0.2% (CsA-LE; Klarity CL) in comparison to commercially available cyclosporine 0.05% (CsA; Restasis) in improving signs and symptoms of dry eye. Methods: This multicenter, prospective, randomized, controlled, open-label study evaluated 60 patients randomized to a single treatment for 4 weeks and evaluated at day 0, day 14, and day 28. Comparison was made of corneal higher-order aberrations (HOAs), dry-eye symptoms (SPEED score), tear-breakup time (TBUT), corneal staining, and ocular hyperemia, as well as tolerability of each medication with the validated COMTOL instrument. Results: A total of 56 patients completed enrollment. Corneal HOAs improved significantly with CsA-LE, but not CsA alone. Both groups showed significant improvement (with no significant differences between groups) in SPEED scores, corneal staining, TBUT, and conjunctival hyperemia. Tolerability was similar between the drugs, and no significant safety issues were identified. Conclusion: The combination of CsA 0.1%-LE 0.2% provided significant improvement in corneal HOAs, while CsA 0.05% did not. For all other measures of ocular surface improvement, both medications showed similar benefits. Tolerability was comparable between the formulations. When rapid rehabilitation of the ocular surface is needed to reduce aberrations, CsA-LE is an appropriate choice.

Localized Heat Treatment for Meibomian Gland Dysfunction: A Single-Center Retrospective Analysis of Efficacy over Time.

SIGNIFICANCE: Meibomian gland dysfunction (MGD) can produce a myriad of symptoms. The effective treatment of MGD can reduce the burden of this condition. Although several studies have indicated that TearCare (Sight Sciences, Menlo Park, CA) is an effective treatment for MGD, no studies currently provide information regarding the duration of efficacy. PURPOSE: The purpose of this analysis was to determine the duration of efficacy of symptom relief and improvement of signs (as measured by gland function) for a treatment consisting of controlled heating of the meibomian glands using SmartLids (Sight Sciences) combined with manual expression of the liquefied meibum by a physician. METHODS: This study involved retrospective analysis of data gathered from a single-center ophthalmology/optometry practice. Symptoms were assessed using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and the signs were assessed using the meibomian gland expression (MGE) scores before and at several time points (8 weeks, 6 months, 12 months, and 18 months). Further analysis evaluating the efficacy in subgroups based on age, race, and sex was performed. RESULTS: There were 78 patients included in this study. The mean baseline SPEED score decreased from 14 to 7.9 at 8 weeks. The mean SPEED scores at 6 and 12 months were maintained at 7.7 and 7.9, respectively, and at 18 months went to 8.9. At baseline, the mean MGE was 4.9 in the right eye and 4.8 in the left eye. In both eyes, the mean MGE increased to 9.0 in both eyes at 8 weeks. At 6 months, the mean MGE score was maintained at 8.6 in the right and 8.2 in the left and remained consistent at 12 months with 7.8 in the right and 7.8 in the left. At 18 months, the MGE score went to 6.8 in the right eye and 7.0 in the left eye. CONCLUSIONS: A single TearCare treatment effectively reduced both the symptoms and signs of MGD and maintained its effects for 12 months.

How Can We Best Diagnose Severity Levels of Dry Eye Disease: Current Perspectives.

Dry eye disease (DED) is a common ocular condition, but the diagnosis relative to other ocular conditions and the evaluation of severity of the condition has often been difficult. This challenge can be due to clinical signs and symptoms not always correlating with each other. An understanding of the various components which create the condition, as well as the diagnostic measures used to evaluate these components, is useful to the clinician working with DED patients. This review paper will discuss traditional diagnostic options, diagnostic imaging, and Advanced Point of Care testing capabilities to determine the severity level of dry eye disease more adequately.

Prospective, Randomized, Fellow Eye-Controlled Study of Postoperative Pain and Inflammation Control with an Intracanalicular Dexamethasone 0.4 mg Ophthalmic Insert Following Small Incision Lenticule Extraction.

Purpose: To compare postoperative anterior chamber inflammation, pain, and patient preference following small incision lenticule extraction (SMILE) in eyes treated with a dexamethasone 0.4 mg intracanalicular insert (DEX) or topical prednisolone acetate (PRED). Patients and Methods: In this prospective, randomized, fellow eye-controlled trial, 20 patients underwent same-day, bilateral SMILE. One randomly-selected eye of each patient received DEX placed immediately postoperatively, and the fellow eye received topical PRED tapered over 2 weeks. Postoperative evaluations were performed on day 1, week 1, month 1, and month 3. Primary outcomes included postoperative pain, incidence of anterior chamber cell and flare, and patient preference of steroid therapy. Results: No eyes in either group had any clinically evident cell or flare at any postoperative time point. Mean pain scores (0-10 by subjective report) and incidence of any pain were statistically similar at all postoperative visits. Uncorrected distance visual acuity improved in all eyes, 91% of which achieved 20/25 or better. No eyes lost any lines of corrected distance visual acuity. Three eyes developed a steroid-related rise in intraocular pressure, all of which resolved with 2 of the 3 eyes requiring topical therapy. At 1 week, 1 month, and 3 months, 70%, 65%, and 53% of patients preferred DEX over PRED therapy, respectively. Conclusion: The DEX insert was preferred by more patients and controlled postoperative inflammation and pain comparably to topical PRED in eyes undergoing SMILE. There were no statistically significant differences in visual outcomes between the two groups.

A Single-center Retrospective Trial of a Blink-assisted Eyelid Device in Treating the Signs and Symptoms of Dry Eye.

SIGNIFICANCE: The clinical features of meibomian gland disease include altered tear film stability, damage to the ocular surface, symptoms of ocular surface irritation, and visual fluctuations. Finding an adequate treatment to alleviate a patient's signs and symptoms is vital to caring for those with dry eye disease resulting from meibomian gland disease. PURPOSE: The purpose of this analysis was to determine whether the controlled heating of meibomian glands with the SmartLid devices (TearCare) combined with evacuation of the liquefied meibum using a handheld clearance assistant would improve a patient's dry eye symptoms (as measured by the Standardized Patient Evaluation of Eye Dryness [SPEED] questionnaire) and signs (as measured by meibomian gland expression [MGE] scores). METHODS: This study involved a retrospective analysis of data gathered in a single-center ophthalmology/optometry practice. The symptom frequency and severity were assessed using the SPEED questionnaire, and the signs were assessed via MGE scores before and after (8 to 12 weeks) treatment. A further analysis evaluating efficacy in subgroups based on age, race, and sex was performed. A statistical analysis was performed with t tests for group comparisons. RESULTS: A SPEED questionnaire was answered by 92 patients with dry eye disease. In addition, each patient's meibomian gland function was recorded as MGE scores for each eye (176 eyes). These procedures were completed before and approximately 8 weeks after a single bilateral TearCare treatment. The median total SPEED score was reduced from 16 to 9, and the total MGE scores improved from 5.0 to 9.0 in the right eye and 4.0 to 9.0 in the left eye after a single TearCare treatment. CONCLUSIONS: A single TearCare treatment was effective in reducing both the signs and symptoms of dry eye in all subjects.

Further considerations of exact equations for peak capacity in isocratic liquid chromatography.

Further consideration is made of the exact equation for peak capacity by Potts, L. W.; Carr, P. W. Anal. Chem. 2011, 83, 7614-7615 for liquid chromatographs with significant extra-column broadening. Equivalent exact equations are easily derived that provide comprehension and insight of how extra-column broadening degrades chromatographic performance as measured by peak capacity.

A clustering of immune-mediated polyradiculoneuropathy among swine abattoir workers exposed to aerosolized porcine brains, Indiana, United States.

In November 2007 a novel neuropathy, immune-mediated polyradiculoneuropathy (IP), was identified among workers at a Minnesota swine abattoir where a unique compressed air technique was used to remove porcine brains. An epidemiologic investigation at another abattoir in Indiana that also uses this process was launched to evaluate workers self-reporting neurologic illness compatible with IP. A nested case-control study was performed to identify cases and risk factors. Six confirmed, one probable, and three possible IP cases were detected. IP cases were 28-52 years old, of Latino origin, and 62.5% female. Onset dates ranged from April 2005-December 2007; 60% were hospitalized. IP cases at this plant were similar in clinical presentation and exposure risks to those detected in Minnesota. Swine abattoirs using similar brain extraction methods should discontinue this process.

Effect of phase ratio on van't Hoff analysis in reversed-phase liquid chromatography, and phase-ratio-independent estimation of transfer enthalpy.

In analysis of the thermodynamics of the transfer of a solute from the mobile phase to the stationary phase in reversed-phase liquid chromatography, it is nearly always assumed that the phase ratio is constant. This type of analysis is typically performed by applying a form of the van't Hoff equation, which relates the retention factor to temperature via the enthalpy and entropy of transfer. When non-linear van't Hoff plots are observed, it is often assumed that the enthalpy and entropy of transfer change with temperature. However, when the possibility of a change in the phase ratio is considered, it becomes apparent that non-linear van't Hoff behavior may or may not be due to changes in enthalpy or entropy. In this work, we present mathematical evidence that phase ratio changes, if they occur, can cause deviations from linearity in a van't Hoff plot. We also show that the phase ratio influence can be eliminated by considering the molecular difference between two solutes instead of the solutes themselves. The resulting selectivity van't Hoff plots may be linear, even when the van't Hoff plots of the two solutes are non-linear. In such cases, temperature-dependent phase ratio changes, and not necessarily changes in the transfer enthalpy, may be responsible for the curved van't Hoff plots of the individual solutes. In addition, we present chromatographic evidence that different solutes may "see" different thermodynamic phase ratios. It is clear that the concept of a phase ratio in reversed-phase chromatography is not nearly as well defined as a phase ratio in a bulk system like a liquid-liquid extraction.