OBJECTIVE: To compare the efficacy and safety of cyclosporin A ([CsA] 0.05% and 0.1% ophthalmic emulsions) to vehicle in patients with moderate to severe dry eye disease. DESIGN: Multicenter, randomized, double-masked, parallel-group, 6-month, vehicle-controlled. PARTICIPANTS: A total of 877 patients with defined moderate to severe dry eye disease (292 to 293 in each treatment group). METHODS: Two identical clinical trials; patients were treated twice daily with either CsA, 0.05% or 0.1%, or vehicle. The results of these two trials were combined for analysis. EFFICACY: corneal and interpalpebral dye staining, Schirmer tear test (with and without anesthesia), tear break-up time, Ocular Surface Disease Index (OSDI), facial expression, patient subjective rating scale, symptoms of dry eye, investigator's evaluation of global response to treatment, treatment success, and daily use of artificial tears. SAFETY: occurrence of adverse events, best-corrected visual acuity, intraocular pressure, biomicroscopy, and blood trough CsA concentrations. RESULTS: Treatment with CsA, 0.05% or 0.1%, gave significantly (P < or = 0.05) greater improvements than vehicle in two objective signs of dry eye disease (corneal staining and categorized Schirmer values). CsA 0.05% treatment also gave significantly greater improvements (P < 0.05) in three subjective measures of dry eye disease (blurred vision, need for concomitant artificial tears, and the physician's evaluation of global response to treatment). There was no dose-response effect. Both CsA treatments exhibited an excellent safety profile, and there were no significant topical or systemic adverse safety findings. CONCLUSIONS: The novel ophthalmic formulations CsA 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease yielding improvements in both objective and subjective measures. Topical CsA represents a new pharmacologically based treatment for dry eye disease that may provide significant patient benefits.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of cyclosporin A ([CsA] 0.05% and 0.1% ophthalmic emulsions) to vehicle in patients with moderate to severe dry eye disease. DESIGN: Multicenter, randomized, double-masked, parallel-group, 6-month, vehicle-controlled. PARTICIPANTS: A total of 877 patients with defined moderate to severe dry eye disease (292 to 293 in each treatment group). METHODS: Two identical clinical trials; patients were treated twice daily with either CsA, 0.05% or 0.1%, or vehicle. The results of these two trials were combined for analysis. EFFICACY: corneal and interpalpebral dye staining, Schirmer tear test (with and without anesthesia), tear break-up time, Ocular Surface Disease Index (OSDI), facial expression, patient subjective rating scale, symptoms of dry eye, investigator's evaluation of global response to treatment, treatment success, and daily use of artificial tears. SAFETY: occurrence of adverse events, best-corrected visual acuity, intraocular pressure, biomicroscopy, and blood trough CsA concentrations. RESULTS: Treatment with CsA, 0.05% or 0.1%, gave significantly (P < or = 0.05) greater improvements than vehicle in two objective signs of dry eye disease (corneal staining and categorized Schirmer values). CsA 0.05% treatment also gave significantly greater improvements (P < 0.05) in three subjective measures of dry eye disease (blurred vision, need for concomitant artificial tears, and the physician's evaluation of global response to treatment). There was no dose-response effect. Both CsA treatments exhibited an excellent safety profile, and there were no significant topical or systemic adverse safety findings. CONCLUSIONS: The novel ophthalmic formulations CsA 0.05% and 0.1% were safe and effective in the treatment of moderate to severe dry eye disease yielding improvements in both objective and subjective measures. Topical CsA represents a new pharmacologically based treatment for dry eye disease that may provide significant patient benefits.
Authors: C S De Paiva; J K Raince; A J McClellan; K P Shanmugam; S B Pangelinan; E A Volpe; R M Corrales; W J Farley; D B Corry; D-Q Li; S C Pflugfelder Journal: Mucosal Immunol Date: 2010-12-22 Impact factor: 7.313
Authors: Yoshihiro Inamoto; Nuria Valdés-Sanz; Yoko Ogawa; Monica Alves; Luigi Berchicci; John Galvin; Hildegard Greinix; Gregory A Hale; Biljana Horn; Debra Kelly; Hien Liu; Scott Rowley; Helene Schoemans; Ami Shah; Maria Teresa Lupo Stanghellini; Vaibhav Agrawal; Ibrahim Ahmed; Asim Ali; Neel Bhatt; Michael Byrne; Saurabh Chhabra; Zachariah DeFilipp; Kristina Fahnehjelm; Nosha Farhadfar; Erich Horn; Catherine Lee; Sunita Nathan; Olaf Penack; Pinki Prasad; Seth Rotz; Alicia Rovó; Jean Yared; Steven Pavletic; Grzegorz W Basak; Minoo Battiwalla; Rafael Duarte; Bipin N Savani; Mary E D Flowers; Bronwen E Shaw; Igor Petriček Journal: Biol Blood Marrow Transplant Date: 2018-11-24 Impact factor: 5.742
Authors: Srihari Narayanan; Rachel L Redfern; William L Miller; Kelly K Nichols; Alison M McDermott Journal: Ocul Surf Date: 2013-01-29 Impact factor: 5.033