PurposeDry eye disease (DED) has a multifactorial etiology, including insufficient tear production and/or excessive tear evaporation linked to multiple conditions. A preservative‐free eye drop formulation containing sodium hyaluronate and trehalose (SH‐THL, Thealoz® Duo) capitalizes on the bioprotectant properties of trehalose. This study evaluated the improvement of ocular surface disease (OSD), dry eye signs and symptoms, treatment satisfaction in patients with DED receiving SH‐THL.MethodsMulti‐center, international, non‐interventional prospective survey lasting 84 days with up to 2 post‐baseline visits in up to 310 adult subjects with clinically confirmed DED requiring artificial tears. Clinical signs with Schirmer Test, tear Break Up Time, hyperemia, dry eye symptoms with OSDI® scale and the five‐item dry eye questionnaire (DEQ‐5) as well as patient satisfaction were assessed at baseline, visit 1 (28 days) and 2 (84 days). SH‐THL was to be instilled when needed. The number of eye drops instilled per day was determined using the Kali Care Drop Meter (n=42).ResultsData from 238 patients were analyzed. 83.2% were women, the mean age was 57.9 ± 15.1 years. At baseline, the overall OSDI was 42.2 ± 19.9 and 61.3% of patients had severe OSDI. The DEQ‐5 score was 12.4±4.1 and the patient treatment satisfaction score was 6.4 ± 2.1. The OSDI significantly improved (p < 0.001) after 84 days. The DEQ‐5 score significantly improved at visit 1, persisting until visit 2 (both p < 0.001) with a statistically significant (p = 0.002) difference between visit 1 and 2. Patient satisfaction with treatment significantly improved (p < 0.001) at visit 1 and 2 compared to baseline. All clinical signs significantly improved after 84 days of SH‐THL.ConclusionsResults confirm that continued use of eye drops containing SH‐THL reduced DED signs and symptoms, OSDI scores, and result in a very high patient satisfaction.
Purpose Objectives: To evaluate progressive changes in visual function parameters in patients with Fuchs endotelial dystrophy (FED) who underwent Descemet membrane endotelial keratoplasty (DMEK) and to compare visual results after DMEK with visual function parameters in healthy subjects without corneal pathology. Methods Methods: Fourteen patients (14 eyes) with FED who underwent DMEK surgery were included in the study. All subjects underwent best corrected visual acuity (BCVA) evaluation using the ETDRS optotype in photopic and scotopic conditions, and contrast sensitivity (CS) assessment using the CSV 1000 and the Pelli Robson tests in different lighting conditions, preoperatively, at 1 and 6 months after surgery. Fourteen eyes of 14 healthy controls were evaluated using the same protocol and compared with the patients’ final postsurgery data. Results Results: A significant improvement in all visual function parameters was observed in patients 1 month (p < 0.05) and 6 months (p < 0.05) after DMEK, compared with preoperative levels. Healthy controls had significantly higher BCVA in photopic and scotopic conditions (p = 0.02, p = 0.044, respectively), better CS in spatial frequencies of 6 cpd (p < 0.001); 12 cpd (p = 0.006) and 18 cpd (p = 0.006) measured with the CSV 1000 test, and CS as measured with the Pelli Robson test (p = 0.002). No significant differences were observed between patients and healthy controls in the spatial frequency of 3 cpd (photopic, p = 0.704; mesopic, p = 0.596; mesopic with glare, p = 0.989). Conclusions Conclusions: DMEK improves visual function parameters in patients with FED in the first month after surgery. Patients who underwent DMEK present similar CS to healthy subjects in lower frequencies. However, BCVA and CS in medium and high frequencies remain significantly lower than those values found in healthy corneas.
Background: Successful integration of in vitro into in vivo data on drug-drug interaction (DDI) is dependent on the inhibitory concentration used. Obtaining plasma concentration of a drug is only readily available for a small number of drugs in clinical practice, and so we propose the use of a therapeutic range as a substitute for inhibitory concentration. Objective: Because of this, we aimed to construct a linear-regression model based on the area-under-curve of the victim drugs and the therapeutic range, for a set of known inhibitors of the CYP2D6 of interest. Methods: Correlation analysis of linear log-log regression of two main variables: the area-under-curve ratio (AUCr) of the victim drugs and of the therapeutic range-to-inhibition constant ratio, with data obtained from literature. Results: Data were fitted to a linear log-log regression, between the average of the AUCr values and the mean value of the therapeutic range-to-inhibition constant ratio (TRm-to-Ki), of the inhibitory drugs. Conclusions: According to our results, knowledge of the inhibition constant and therapeutic range (or its plasma levels if disponible) of the inhibitor would be sufficient to determine the intensity and clinical relevance of a CYP2D6-mediated DDI.
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