An artificial tear containing flaxseed oil for treating dry eye disease: A randomized controlled trial
Laura E Downie, Milton M Hom, Gregg J Berdy, Sherif El-Harazi, Anthony Verachtert, Jacqueline Tan, Haixia Liu, Cindy Carlisle-Wilcox, Peter Simmons, Joseph Vehige
The Ocular Surface | ELSEVIER | Published : 2020
PURPOSE: To evaluate the efficacy and safety of a nano-emulsion artificial tear (OM3) containing carboxymethylcellulose (CMC) and glycerin, flaxseed oil and castor oil, and three osmoprotectants (levocarnitine, erythritol, and trehalose) compared with an artificial tear (Refresh Optive Advanced [ROA]) containing the same ingredients with the exception of trehalose and flaxseed oil. METHODS: In this multicenter, double-masked, randomized, two-arm, parallel-group, 6-visit study (screening, baseline, and days 7, 30, 60, and 90), subjects with dry eye disease underwent an open-label, 7-day run-in with CMC 0.5% (Refresh Plus), before 1:1 randomization to OM3 or ROA for 90 days (both instilled ≥2 ..View full abstract
This study was funded by Allergan plc, Irvine, CA. L. Downie has received financial support from Alcon, Allergan, CooperVision and Azura Ophthalmics. M. Hom has received financial support from Allergan, Bausch & Lomb, and Takeda. G. Berdy has received financial support from Alcon, Allergan, Bausch & Lomb, Parion, Shire, and Sun Pharma. S. El-Harazi has received financial support from Allergan. A. Verachtert has received financial support from Allergan. J. Tan has received financial support from Alcon, Allergan, Azura Ophthalmics, CooperVision, Menicon, and Ophtecs. H. Liu and C. Carlisle-Wilcox are employees of Allergan plc, Irvine, CA. P. Simmons and J. Vehige were employees of Allergan plc, Irvine, CA, at the time the study was conducted.Medical writing and editorial assistance were provided to the authors by Stuart Murray and Scarlett Geunes-Boyer of Evidence Scientific Solutions, Inc, Philadelphia, Pennsylvania, and funded by Allergan plc, Dublin, Ireland. All authors met the ICMJE authorship criteria. No honoraria or payments were made for authorship.