Comment to: Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial Commentary
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Published:
Mar 14, 2022
Keywords:
sacha inchi (Plukenetia volubilis), multi-ingredient sacha inchi microemulsion (SIME), dry eye disease
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Abstract
Sacha inchi (Plukenetia volubilis) is an oil plant native to tropical rainforests in South America. The seeds of the plant are a potential source of macro- and microelements, α-linolenic acid and phytochemicals.
A single-centre, prospective, masked clinical study was designed to investigate the efficacy and safety of multi-ingredient sacha inchi microemulsion (SIME) eye drops in the treatment of patients with dry disease.
Sacha inchi microemulsion (SIME) proved safe and efficacious in re-establishing the physiological protective tear film function and restoring the homeostasis of the ocular surface.
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1.
Nowińska A. Comment to: Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Ophthatherapy [Internet]. 2022Mar.14 [cited 2024Nov.23];9(1):46-2. Available from: https://journalsmededu.pl/index.php/ophthatherapy/article/view/1771
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Conservative treatment
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References
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13. Cagini C, Torroni G, Mariniello M et al. Trehalose/sodium hyaluronate eye drops in post-cataract ocular surface disorders. Int Ophthalmol. 2021; 41: 3065-71.
14. Haji-Ali-Nili N, Khoshzaban F, Karimi M et al. Effect of a Natural Eye Drop, Made of Plantago Ovata Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial. Iran J Pharm Res IJPR. 2019; 18: 1602-11. http://doi.org/10.22037/IJPR.2019.1100717.
15. Labetoulle M, Chiambaretta F, Shirlaw A et al. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017; 31: 1409-16. http://doi.org/10.1038/EYE.2017.73.
16. Jun JH, Bang SP, Park HS et al. A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye. Jpn J Ophthalmol. 2022; 66: 58-67. http://doi.org/10.1007/S10384-021-00885-X.
17. Cagini C, Di Lascio G, Torroni G et al. Dry eye and inflammation of the ocular surface after cataract surgery: effectiveness of a tear film substitute based on trehalose/hyaluronic acid vs hyaluronic acid to resolve signs and symptoms. J Cataract Refract Surg. 2021; 47: 1430-5.
18. Brar S, Vanga HR, Ganesh S. Comparison of efficacy of trehalose-based eye drops versus topical 0.1% Hyaluronic Acid for management of clinically significant dry eye using non-invasive investigational modalities. Int Ophthalmol. 2021; 41: 3349-59.
19. Shiraishi A, Sakane Y. Assessment of dry eye symptoms: Current trends and issues of dry eye questionnaires in Japan. Invest Ophthalmol Vis Sci. 2018; 59(14): DES23-DES28. http://doi.org/10.1167/iovs.18-24570.
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21. Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003; 22: 640-50. http://doi.org/10.1097/00003226-200310000-00008.
22. Baudouin C. [A new approach for better comprehension of diseases of the ocular surface]. J Fr Ophtalmol. 2007; 30: 239-46. http://doi.org/10.1016/S0181-5512(07)89584-2.
23. Chirinos R, Pedreschi R, Domínguez G et al. Comparison of the physico-chemical and phytochemical characteristics of the oil of two Plukenetia species. Food Chem. 2015; 173: 1203–6. http://doi.org/10.1016/J.FOODCHEM.2014.10.120.
24. Wang S, Zhu F, Kakuda Y. Sacha inchi (Plukenetia volubilis L.): Nutritional composition, biological activity, and uses. Food Chem. 2018; 265: 316-28. http://doi.org/10.1016/J.FOODCHEM.2018.05.055.
25. Simmons PA, Carlisle-Wilcox C, Chen R et al. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015; 37: 858-68. http://doi.org/10.1016/J.CLINTHERA.2015.01.001.
26. opis odsyła Kojima T, Nagata T, Kudo H et al. The Effects of High Molecular Weight Hyaluronic Acid Eye Drop Application in Environmental Dry Eye Stress Model Mice. Int J Mol Sci. 2020; 21. http://doi.org/10.3390/IJMS21103516cza.
27. Čejková J, Čejka Č, Luyckx J. Trehalose treatment accelerates the healing of UVB-irradiated corneas. Comparative immunohistochemical studies on corneal cryostat sections and corneal impression cytology. Histol Histopathol. 2012; 27: 1029-40. http://doi.org/10.14670/HH-27.1029.
28. Čejková J, Ardan T, Čejka Č et al. Favorable effects of trehalose on the development of UVB-mediated antioxidant/pro-oxidant imbalance in the corneal epithelium, proinflammatory cytokine and matrix metalloproteinase induction, and heat shock protein 70 expression. Graefe’s Arch Clin Exp Ophthalmol. 2011; 249: 1185-94.
29. Cejka C, Kubinova S, Čejková J. Trehalose in ophthalmology. Histol Histopathol. 2019; 34: 611-8.
30. Panigrahi T, Shivakumar S, Shetty R et al. Trehalose augments autophagy to mitigate stress induced inflammation in human corneal cells. Ocul Surf. 2019; 17: 699-713. http://doi.org/10.1016/J.JTOS.2019.08.004.
2. Lemp MA, Baudouin C, Baum J et al. The definition and classification of dry eye disease: report of the Definition and ClassificationSubcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007; 5: 75-92. http://doi.org/10.1016/S1542-0124(12)70081-2.
3. Stapleton F, Alves M, Bunya VY et al. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017; 15: 334-65. http://doi.org/10.1016/J.JTOS.2017.05.003.
4. Zhang X, Wang L, Zheng Y et al. Prevalence of dry eye disease in the elderly: A protocol of systematic review and meta-analysis. Medicine (Baltimore). 2020; 99: e22234.
5. Song P, Xia W, Wang M et al. Variations of dry eye disease prevalence by age, sex and geographic characteristics in China: a systematic review and meta-analysis. J Glob Health. 2018; 8. http://doi.org/10.7189/JOGH.08.020503.
6. Nelson JD, Shimazaki J, Benitez-del-Castillo JM et al. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011; 52: 1930-7. http://doi.org/10.1167/IOVS.10-6997B.
7. Matossian C, McDonald M, Donaldson KE et al. Dry Eye Disease: Consideration for Women’s Health. J Women’s Heal. 2019; 28: 502. http://doi.org/10.1089/JWH.2018.7041.
8. Laihia J, Järvinen R, Wylęgała E et al. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020; 98: 244-54. http://doi.org/10.1111/AOS.14252.
9. Bron AJ, de Paiva CS, Chauhan SK et al. TFOS DEWS II pathophysiology report. Ocul Surf. 2017; 15: 438-510. http://doi.org/10.1016/J.JTOS.2017.05.011.
10. Bron AJ, de Paiva CS, Chauhan SK et al. Corrigendum to “TFOS DEWS II pathophysiology report” (The Ocular Surface (2017) 15(3) (438- 510), (S1542012417301349), (10.1016/j.jtos.2017.05.011)). Ocul Surf. 2019; 17: 842.
11. Wolffsohn JS, Arita R, Chalmers R et al. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017; 15: 539-74.
12. Shin J, Rho CR, Hyon JY et al. A Randomized, Placebo-Controlled Phase II Clinical Trial of 0.01% or 0.02% Cyclosporin A with 3% Trehalose in Patients with Dry Eye Disease. J Ocul Pharmacol Ther. 2021; 37: 4-11. http://doi.org/10.1089/JOP.2020.0104.
13. Cagini C, Torroni G, Mariniello M et al. Trehalose/sodium hyaluronate eye drops in post-cataract ocular surface disorders. Int Ophthalmol. 2021; 41: 3065-71.
14. Haji-Ali-Nili N, Khoshzaban F, Karimi M et al. Effect of a Natural Eye Drop, Made of Plantago Ovata Mucilage on Improvement of Dry Eye Symptoms: A Randomized, Double-blind Clinical Trial. Iran J Pharm Res IJPR. 2019; 18: 1602-11. http://doi.org/10.22037/IJPR.2019.1100717.
15. Labetoulle M, Chiambaretta F, Shirlaw A et al. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017; 31: 1409-16. http://doi.org/10.1038/EYE.2017.73.
16. Jun JH, Bang SP, Park HS et al. A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye. Jpn J Ophthalmol. 2022; 66: 58-67. http://doi.org/10.1007/S10384-021-00885-X.
17. Cagini C, Di Lascio G, Torroni G et al. Dry eye and inflammation of the ocular surface after cataract surgery: effectiveness of a tear film substitute based on trehalose/hyaluronic acid vs hyaluronic acid to resolve signs and symptoms. J Cataract Refract Surg. 2021; 47: 1430-5.
18. Brar S, Vanga HR, Ganesh S. Comparison of efficacy of trehalose-based eye drops versus topical 0.1% Hyaluronic Acid for management of clinically significant dry eye using non-invasive investigational modalities. Int Ophthalmol. 2021; 41: 3349-59.
19. Shiraishi A, Sakane Y. Assessment of dry eye symptoms: Current trends and issues of dry eye questionnaires in Japan. Invest Ophthalmol Vis Sci. 2018; 59(14): DES23-DES28. http://doi.org/10.1167/iovs.18-24570.
20. Ousler GW, Hagberg KW, Schindelar M et al. The Ocular Protection Index. Cornea. 2008; 27: 509-13. http://doi.org/10.1097/ICO.0B013E31816583F6.
21. Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003; 22: 640-50. http://doi.org/10.1097/00003226-200310000-00008.
22. Baudouin C. [A new approach for better comprehension of diseases of the ocular surface]. J Fr Ophtalmol. 2007; 30: 239-46. http://doi.org/10.1016/S0181-5512(07)89584-2.
23. Chirinos R, Pedreschi R, Domínguez G et al. Comparison of the physico-chemical and phytochemical characteristics of the oil of two Plukenetia species. Food Chem. 2015; 173: 1203–6. http://doi.org/10.1016/J.FOODCHEM.2014.10.120.
24. Wang S, Zhu F, Kakuda Y. Sacha inchi (Plukenetia volubilis L.): Nutritional composition, biological activity, and uses. Food Chem. 2018; 265: 316-28. http://doi.org/10.1016/J.FOODCHEM.2018.05.055.
25. Simmons PA, Carlisle-Wilcox C, Chen R et al. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015; 37: 858-68. http://doi.org/10.1016/J.CLINTHERA.2015.01.001.
26. opis odsyła Kojima T, Nagata T, Kudo H et al. The Effects of High Molecular Weight Hyaluronic Acid Eye Drop Application in Environmental Dry Eye Stress Model Mice. Int J Mol Sci. 2020; 21. http://doi.org/10.3390/IJMS21103516cza.
27. Čejková J, Čejka Č, Luyckx J. Trehalose treatment accelerates the healing of UVB-irradiated corneas. Comparative immunohistochemical studies on corneal cryostat sections and corneal impression cytology. Histol Histopathol. 2012; 27: 1029-40. http://doi.org/10.14670/HH-27.1029.
28. Čejková J, Ardan T, Čejka Č et al. Favorable effects of trehalose on the development of UVB-mediated antioxidant/pro-oxidant imbalance in the corneal epithelium, proinflammatory cytokine and matrix metalloproteinase induction, and heat shock protein 70 expression. Graefe’s Arch Clin Exp Ophthalmol. 2011; 249: 1185-94.
29. Cejka C, Kubinova S, Čejková J. Trehalose in ophthalmology. Histol Histopathol. 2019; 34: 611-8.
30. Panigrahi T, Shivakumar S, Shetty R et al. Trehalose augments autophagy to mitigate stress induced inflammation in human corneal cells. Ocul Surf. 2019; 17: 699-713. http://doi.org/10.1016/J.JTOS.2019.08.004.