Formulation and In Vitro Evaluation of Cyclosporine-A Inserts Prepared Using Hydroxypropyl Methylcellulose for Treating Dry Eye Disease

2016 ◽  
Vol 32 (7) ◽  
pp. 451-462 ◽  
Author(s):  
Zahraa H.F. Al-Saedi ◽  
Rami M. Alzhrani ◽  
Sai H.S. Boddu
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Hydroxypropyl Methylcellulose ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
In Vitro Evaluation

scholarly journals One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

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.

Author's Reply to: “Concerns Over: Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease”

2017 ◽  
Vol 27 (6) ◽  
pp. e194-e195
Author(s):  
Andrea Leonardi ◽  
Gysbert Van Setten ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sebastien Garrigue ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety

scholarly journals Lipid Annotation by Combination of UHPLC-HRMS (MS), Molecular Networking, and Retention Time Prediction: Application to a Lipidomic Study of In Vitro Models of Dry Eye Disease

Metabolites ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 225 ◽  
Author(s):  
Romain Magny ◽  
Anne Regazzetti ◽  
Karima Kessal ◽  
Gregory Genta-Jouve ◽  
Christophe Baudouin ◽  
...  
Keyword(s):  
Dry Eye ◽  
Retention Time ◽  
Inflammatory Responses ◽  
In Vitro Models ◽  
Dry Eye Disease ◽  
Molecular Networks ◽  
Chromatographic Behavior ◽  
Eye Disease ◽  
Molecular Networking

Annotation of lipids in untargeted lipidomic analysis remains challenging and a systematic approach needs to be developed to organize important datasets with the help of bioinformatic tools. For this purpose, we combined tandem mass spectrometry-based molecular networking with retention time (tR) prediction to annotate phospholipid and sphingolipid species. Sixty-five standard compounds were used to establish the fragmentation rules of each lipid class studied and to define the parameters governing their chromatographic behavior. Molecular networks (MNs) were generated through the GNPS platform using a lipid standards mixture and applied to lipidomic study of an in vitro model of dry eye disease, i.e., human corneal epithelial (HCE) cells exposed to hyperosmolarity (HO). These MNs led to the annotation of more than 150 unique phospholipid and sphingolipid species in the HCE cells. This annotation was reinforced by comparing theoretical to experimental tR values. This lipidomic study highlighted changes in 54 lipids following HO exposure of corneal cells, some of them being involved in inflammatory responses. The MN approach coupled to tR prediction thus appears as a suitable and robust tool for the discovery of lipids involved in relevant biological processes.

scholarly journals Manganese(III) tetrakis(1-methyl-4-pyridyl) porphyrin, a superoxide dismutase mimetic, reduces disease severity in in vitro and in vivo models for dry-eye disease

2019 ◽  
Vol 17 (2) ◽  
pp. 257-264 ◽  
Author(s):  
Agnė Žiniauskaitė ◽  
Symantas Ragauskas ◽  
Anita K. Ghosh ◽  
Rubina Thapa ◽  
Anne E. Roessler ◽  
...  
Keyword(s):  
Superoxide Dismutase ◽  
Disease Severity ◽  
Dry Eye ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
In Vivo Models

scholarly journals Development of Lactoferrin-Loaded Liposomes for the Management of Dry Eye Disease and Ocular Inflammation

Pharmaceutics ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 1698
Author(s):  
Ana López-Machado ◽  
Natalia Díaz-Garrido ◽  
Amanda Cano ◽  
Marta Espina ◽  
Josefa Badia ◽  
...  
Keyword(s):  
Dry Eye ◽  
Ex Vivo ◽  
Visual Disturbance ◽  
Nasolacrimal Duct ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Lipid Film ◽  
Anti Inflammatory

Dry eye disease (DED) is a high prevalent multifactorial disease characterized by a lack of homeostasis of the tear film which causes ocular surface inflammation, soreness, and visual disturbance. Conventional ophthalmic treatments present limitations such as low bioavailability and side effects. Lactoferrin (LF) constitutes a promising therapeutic tool, but its poor aqueous stability and high nasolacrimal duct drainage hinder its potential efficacy. In this study, we incorporate lactoferrin into hyaluronic acid coated liposomes by the lipid film method, followed by high pressure homogenization. Pharmacokinetic and pharmacodynamic profiles were evaluated in vitro and ex vivo. Cytotoxicity and ocular tolerance were assayed both in vitro and in vivo using New Zealand rabbits, as well as dry eye and anti-inflammatory treatments. LF loaded liposomes showed an average size of 90 nm, monomodal population, positive surface charge and a high molecular weight protein encapsulation of 53%. Biopharmaceutical behaviour was enhanced by the nanocarrier, and any cytotoxic effect was studied in human corneal epithelial cells. Developed liposomes revealed the ability to reverse dry eye symptoms and possess anti-inflammatory efficacy, without inducing ocular irritation. Hence, lactoferrin loaded liposomes could offer an innovative nanotechnological tool as suitable approach in the treatment of DED.

scholarly journals Once-Daily Cyclosporine-A-MiDROPS for Treatment of Dry Eye Disease

2018 ◽  
Vol 7 (5) ◽  
pp. 24 ◽  
Author(s):  
Terry G. Coursey ◽  
Ronald A. Wassel ◽  
Alexander B. Quiambao ◽  
Rafal A. Farjo
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Once Daily
Sign in / Sign up

Export Citation Format

Share Document