Efficacy and Safety of a Cationic Emulsion in the Treatment of Moderate to Severe Dry Eye Disease: A Randomized Controlled Study

2016 ◽  
Vol 26 (6) ◽  
pp. 546-555 ◽  
Author(s):  
Pierre-Yves Robert ◽  
Béatrice Cochener ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sébastien Garrigue ◽  
...  
2020 ◽  
Author(s):  
Mostafa Yakoot ◽  
Basem Eysa ◽  
Essam Gouda ◽  
Andrew Hill ◽  
Sherine A. Helmy ◽  
...  

Author(s):  
Ganesh Narain Saxena ◽  
Saumya Mathur

ABSTRACT Introduction Dyspepsia is a clinical problem of considerable magnitude for the healthcare system due to the high prevalence and chronic and recurrent nature of symptoms. Earlier dyspepsia was referred to as a heterogeneous group of symptoms in the upper abdomen and retrosternal which are related to ingestion of meals and include heartburn, regurgitation, epigastric pain, epigastric burning, postprandial fullness/distension, early satiety, bloating, belching, anorexia, nausea, and vomiting. This has prompted the search for newer agents with equal efficacy but lower side effect potential such as levosulpiride and itopride. Aim and objectives To evaluate and compare the efficacy of the newer drugs like levosulpiride and itopride in functional dyspepsia. Observations and results The most common presenting symptoms in the present study were epigastric fullness (81%), upper abdominal pain (55%), early satiety (52%), and epigastric burning (45%). Less common symptoms were bloating (27%), belching (11%), heartburn (10%), and nausea (8%). Conclusion Drugs, itopride and levosulpiride, were equally effective in ameliorating different symptoms of functional dyspepsia at the end of 4 weeks of treatment. There was a significant reduction in mean global symptom score (GSS) and mean duration score and mean score of severity in follow-up visits at the 2nd and 4th week from the day of presentation (p value < 0.05). How to cite this article Saxena GN, Mathur S. A Randomized Controlled Study of Efficacy and Safety Profile of Levosulpiride and Itopride in Functional Dyspepsia. J Mahatma Gandhi Univ Med Sci Tech 2020;5(2):50–56.


Heart Rhythm ◽  
2020 ◽  
Vol 17 (9) ◽  
pp. 1510-1518 ◽  
Author(s):  
Cristiano F. Pisani ◽  
Jorge Romero ◽  
Sissy Lara ◽  
Carina Hardy ◽  
Muhieddine Chokr ◽  
...  

2018 ◽  
Vol Volume 12 ◽  
pp. 2499-2508 ◽  
Author(s):  
Marc Labetoulle ◽  
Stefanie Schmickler ◽  
David Galarreta ◽  
Daniel Boehringer ◽  
Abayomi Ogundele ◽  
...  

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  

Purpose The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE). Methods In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups). Results A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA. Conclusions In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.


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