Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease

2017 ◽  
Vol 43 (1) ◽  
pp. 57-63 ◽  
Author(s):  
José Pinto-Fraga ◽  
Alberto López-de la Rosa ◽  
Francisco Blázquez Arauzo ◽  
Rubén Urbano Rodríguez ◽  
María J. González-García
2018 ◽  
Vol Volume 12 ◽  
pp. 2499-2508 ◽  
Author(s):  
Marc Labetoulle ◽  
Stefanie Schmickler ◽  
David Galarreta ◽  
Daniel Boehringer ◽  
Abayomi Ogundele ◽  
...  

2016 ◽  
Vol 26 (6) ◽  
pp. 546-555 ◽  
Author(s):  
Pierre-Yves Robert ◽  
Béatrice Cochener ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sébastien Garrigue ◽  
...  

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.


2017 ◽  
Vol 27 (6) ◽  
pp. e194-e195
Author(s):  
Andrea Leonardi ◽  
Gysbert Van Setten ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sebastien Garrigue ◽  
...  

2020 ◽  
Vol 11 ◽  
Author(s):  
Maoyi Yang ◽  
Zhipeng Hu ◽  
Rensong Yue ◽  
Liangjun Yang ◽  
Boxun Zhang ◽  
...  

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Klemens Fondi ◽  
Piotr A. Wozniak ◽  
Doreen Schmidl ◽  
Ahmed M. Bata ◽  
Katarzyna J. Witkowska ◽  
...  

Purpose. This randomized, observer-masked, crossover study investigated the effect of two hyaluronic acid/trehalose-based containing formulations, with different physical properties, on the signs and symptoms in patients with moderate to severe dry eye disease (DED). Methods. In one group, patients received a mixture of sodium hyaluronate and trehalose (HT, Thealoz Duo®) for use during the day. In the other group, patients received a more viscous formulation consisting of hyaluronic acid, trehalose, and carbomer (HTC-gel, Thealoz Duo Gel) to use pro re nata. Both groups used HTC-gel before going to bed. Clinical standard tests for DED were performed at the beginning and end of each one-week period. Further, patient satisfaction including quality of sleep was assessed using a visual analogue scale. Results. Corneal fluorescein and conjunctival lissamine green staining scores decreased, and tear breakup time (BUT) increased for both groups (p<0.001 each). Mean instillation frequency was 3.1 ± 2.6 drops/day when using HT and 1.9 ± 2.2 drops/day when using HTC-gel (p=0.02). A significant improvement in the quality of sleep was observed with both treatments (p=0.01). Conclusions. Our results show improvement in signs and symptoms of DED in both groups. While instillation of HTC-gel resulted in a lower instillation frequency, both formulations of trehalose showed good clinical efficacy. This trial is registered with NCT02980913.


Author(s):  
Concepción De-Hita-Cantalejo ◽  
María Carmen Sánchez-González ◽  
Carmen Silva-Viguera ◽  
Marta C. García-Romera ◽  
Ricardo Feria-Mantero ◽  
...  

Abstract Purpose To study the treatment efficacy of hyaluronic acid 0.3%, cyanocobalamin (vitamin B12), electrolytes, and P-Plus in menopausal patients with moderate dry eye disease. Methods Thirty female patients of mean age 53.06 ± 5.20 years (45–65) were enrolled in this prospective longitudinal study. Meibomian gland loss assessment was determined using a scale with four levels. The Ocular Surface Disease Index (OSDI) questionnaire, phenol red thread (PRT) test, and tear film break-up time (TFBUT) were also completed by the patients. Tear eye drops were formulated with 0.3 g of sodium hyaluronate, P-Plus ™, vitamin B12, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and SCO® (stabilized complex oxychloride). After 30 days, the patients were re-evaluated. Results The mean meibomian gland loss percentage was 37.97 ± 19.02 % (7.20 to 88.30%). Before treatment, the OSDI was 22.53 ± 14.03 score points (6.25 to 77.08). Posterior OSDI decreased to 16.26 ± 13.69 score points (0.00 to 70.83) (W = 58.00, P < 0.01). Before treatment, PRT was 10.31 ± 4.48 mm (4.00 to 21.00). Posterior PRT increased to 15.41 ± 6.27 mm (4.00 to 21.00) (W = 1520.50, P < 0.01). Before treatment, TFBUT was 6.23 ± 1.75 s (3.00 to 9.00). The posterior TFBUT increased to 8.10 ± 2.06 s (4.00 to 14.00) (W= 1382.50, P < 0.01). Conclusion The hyaluronic acid 0.3% and vitamin B12 eye drops effectively decreased dry eye symptoms in menopausal women and improved tear stability and volume.


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