An artificial tear containing flaxseed oil for treating dry eye disease: A randomized controlled trial
| Autor: | Laura E Downie, Joseph G. Vehige, Anthony Verachtert, Jacqueline Tan, Gregg J. Berdy, Peter A. Simmons, Sherif El-Harazi, Haixia Liu, Cindy Carlisle-Wilcox, Milton M Hom |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Linseed Oil food.ingredient medicine.medical_treatment Dry Eye Syndromes Lubricant Eye Drops Levocarnitine law.invention 03 medical and health sciences 0302 clinical medicine food Linseed oil Randomized controlled trial law Ophthalmology Humans Medicine Ocular Surface Disease Index 030212 general & internal medicine business.industry eye diseases Artificial tears Carboxymethylcellulose Sodium Tears 030221 ophthalmology & optometry sense organs Ophthalmic Solutions business |
| Zdroj: | The Ocular Surface. 18:148-157 |
| ISSN: | 1542-0124 |
| DOI: | 10.1016/j.jtos.2019.11.004 |
| Popis: | 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.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.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%).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. |
| Databáze: | OpenAIRE |
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