Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study
Pasquale Aragona, Jose M Benitez-del-Castillo, Minas T Coroneo, Subhanjan Mukherji, Jacqueline Tan, Evelien Vandewalle, Algis Vingrys, Haixia Liu, Cindy Carlisle-Wilcox, Joseph Vehige, Peter A Simmons
Clinical Ophthalmology | DOVE MEDICAL PRESS LTD | Published : 2020
Purpose: To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye. Methods: A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with a..View full abstract
This study was sponsored by Allergan plc, Dublin, Ireland (prior to acquisition by AbbVie Inc.). Writing and editorial assistance was provided to the authors by Kakuri Omari, PhD, CMPP, and Stuart Murray, MSc, CMPP of Evidence Scientific Solutions, Inc, Philadelphia, PA, and funded by AbbVie Inc. All authors met the ICMJE authorship criteria. Neither honoraria nor payments were made for authorship. The following principal investigators participated in this study: Dr. Parwez Hossain, Southampton, UK; Aravind Reddy, Aberdeen, UK; Prof. Francisco Figueiredo, Newcastle-upon-Tyne, UK; Subhanjan Mukherji, Great Yarmouth, UK; Dr. Ejaz Ansari, Maidstone, UK; Prof. Algis Vingrys, Melbourne, Australia; Dr. Geoffrey Cohn, Sydney, Australia; Dr. Michael A. Coote, Melbourne, Australia; Dr. Mark D. Daniell, Melbourne, Australia; Prof. Minas T. Coroneo, Sydney, Australia; Dr. Jacqueline Tan, Sydney, Australia; Dr. Renuka Bathija, Melbourne, Australia; Prof. Ingeborg Stalmans, Leuven, Belgium; Dr. Laurence Postelmans, Brussels, Belgium; Dr. Christina P. Martinez, Valencia, Spain; Dr. Maite S. de la Maza Serra, Barcelona, Spain; Dr. Jesus M. Iruzubieta, Sevilla, Spain; Prof. Jose M. Benitez-del-Castillo, Madrid, Spain; Dr. Margarita C. Cano, Valladolid, Spain; Dr. Rafael G. Pina, Huelva, Spain; Dr. Sergio P. Sueiro, Vizcaya, Spain; Dr. Stephan Fauquier, Marseille, France; Prof. Pierre-Jean Pisella, Tours, France; Prof. Frederic Chiambaretta, ClermontFerrand, France; Prof. Dominique Bremond-Gignac, Amiens, France; Prof. Beatrice Cochener, Brest, France; Dr. Cedric Schweitzer, Bordeaux, France; Dr. Catherine CreuzotGarcher, Dijon, France; Prof. Daniel Boehringer, Freiburg, Germany; Dr. Katrin Lorenz, Mainz, Germany; Dr. Phillip Steven, Cologne, Germany; Dr. Elisabeth Messmer, Munich, Germany; Dr. Andrei Nestler, Leipzig, Germany; Dr. Jorg M. Koch, Munster, Germany; Prof Berthold Seitz, Homburg Saar, Germany; Dr. Christina Jacobi, Erlangen, Germany; Prof. Andrea Leonardi, Padova, Italy; Dr. Giulio M. Modorati, Milan, Italy; Prof. Marco Nardi, Pisa, Italy; Prof. Ugo Menchini, Firenze, Italy; Prof. Gabriella J. Orsoni, Parma, Italy; Prof. Pasquale Aragona, Messina, Italy; Prof. Yury Astakhov, St. Petersburg, Russia; Prof. Vladimir Brzheskiy, St. Petersburg, Russia; Prof. Valeriy Erichev, Moscow, Russia.