PMID- 31734510
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 1937-5913 (Electronic)
IS  - 1542-0124 (Linking)
VI  - 18
IP  - 1
DP  - 2020 Jan
TI  - An artificial tear containing flaxseed oil for treating dry eye disease: A 
      randomized controlled trial.
PG  - 148-157
LID - S1542-0124(19)30273-3 [pii]
LID - 10.1016/j.jtos.2019.11.004 [doi]
AB  - 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 daily). 
      Ocular Surface Disease Index (OSDI; primary endpoint change from baseline at day 
      90), tear film breakup time (TBUT), and ocular staining 
      (combined/corneal/conjunctival) were assessed; change from baseline in these 
      parameters was calculated at each timepoint. Treatment-related adverse events 
      (AEs) were assessed at each visit. RESULTS: Overall, 242 subjects were randomized 
      (OM3, n = 120; ROA, n = 122). At day 90, significant improvements in OSDI, ocular 
      staining and TBUT were evident in both treatment groups. Significant (P < 0.05) 
      between-group differences in favor of OM3 were observed for combined ocular 
      staining (all timepoints), corneal staining (day 90), and conjunctival staining 
      (day 30). Treatment-related AEs were higher in the ROA (9.8%) versus OM3 (6.7%) 
      group; blurred vision was among the most commonly reported AE (OM3 0% vs ROA 
      4.1%). CONCLUSION: These findings support the application of OM3, a novel 
      preservative-free, nano-emulsion tear formulation with trehalose and flaxseed 
      oil, for the treatment of dry eye disease.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Downie, Laura E
AU  - Downie LE
AD  - Department of Optometry and Vision Sciences, University of Melbourne, Parkville, 
      VIC, Australia. Electronic address: ldownie@unimelb.edu.au.
FAU - Hom, Milton M
AU  - Hom MM
AD  - Canyon City Eyecare, Azusa, CA, USA.
FAU - Berdy, Gregg J
AU  - Berdy GJ
AD  - Washington University School of Medicine, St. Louis, MO, USA; Ophthalmology 
      Associates, St. Louis, MO, USA.
FAU - El-Harazi, Sherif
AU  - El-Harazi S
AD  - Lugene Eye Institute, Glendale, CA, USA.
FAU - Verachtert, Anthony
AU  - Verachtert A
AD  - Moyes Eye Center, Kansas City, MO, USA.
FAU - Tan, Jacqueline
AU  - Tan J
AD  - University of New South Wales, School of Optometry and Vision Science, Sydney, 
      Australia.
FAU - Liu, Haixia
AU  - Liu H
AD  - Allergan Plc, Irvine, CA, USA.
FAU - Carlisle-Wilcox, Cindy
AU  - Carlisle-Wilcox C
AD  - Allergan Plc, Irvine, CA, USA.
FAU - Simmons, Peter
AU  - Simmons P
AD  - University of New South Wales, School of Optometry and Vision Science, Sydney, 
      Australia; Allergan Plc, Irvine, CA, USA.
FAU - Vehige, Joseph
AU  - Vehige J
AD  - Allergan Plc, Irvine, CA, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191114
PL  - United States
TA  - Ocul Surf
JT  - The ocular surface
JID - 101156063
RN  - 0 (Lubricant Eye Drops)
RN  - 0 (Ophthalmic Solutions)
RN  - 8001-26-1 (Linseed Oil)
RN  - K679OBS311 (Carboxymethylcellulose Sodium)
SB  - IM
MH  - Carboxymethylcellulose Sodium
MH  - *Dry Eye Syndromes/drug therapy
MH  - Humans
MH  - Linseed Oil
MH  - *Lubricant Eye Drops
MH  - Ophthalmic Solutions
MH  - Tears
OTO - NOTNLM
OT  - Artificial tears
OT  - Dry eye disease
OT  - Fatty acid
OT  - Flaxseed oil
OT  - Nano-emulsion
OT  - Omega-3
OT  - Trehalose
EDAT- 2019/11/18 06:00
MHDA- 2021/05/15 06:00
CRDT- 2019/11/18 06:00
PHST- 2019/07/21 00:00 [received]
PHST- 2019/10/25 00:00 [revised]
PHST- 2019/11/13 00:00 [accepted]
PHST- 2019/11/18 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2019/11/18 06:00 [entrez]
AID - S1542-0124(19)30273-3 [pii]
AID - 10.1016/j.jtos.2019.11.004 [doi]
PST - ppublish
SO  - Ocul Surf. 2020 Jan;18(1):148-157. doi: 10.1016/j.jtos.2019.11.004. Epub 2019 Nov 
      14.