Abstract
Purpose
To compare the efficacy of trehalose-HA eye drops versus 0.1% hyaluronic acid for the treatment of dry eye.
Methods
This prospective, comparative, contralateral eye study included sixty eligible patients (mean age 44.13 ± 14.53 years). Patients having a SPEED questionnaire score of 16 or above, objective scatter index (OSI) > 1 and non-invasive tear break up time (NIBUT) of 10 s or less were included in the study. Eyes were randomized to receive 0.1% hyaluronic acid (HA) in one eye and trehalose-HA eye drops in the contralateral eye. At baseline, 1- and 3-month follow-ups, OSI, NIBUT, MG loss, tear meniscus height (TMH) and tear film osmolarity (TFO) were evaluated using non-invasive modalities
Results
There was a statistically significant improvement in NIBUT, TMH, OSI, SPEED questionnaire score in the trehalose-HA compared to the 0.1% HA group at both 1- and 3-month visits (p < 0.05). In both the study groups, compared to the baseline, the mean values of TFO, MG loss, OSI and SPEED questionnaire score significantly reduced at 3 months (p < 0.05). The mean values of NIBUT and tear meniscus height on the other hand showed a significant increase compared to the baseline values (p < 0.05). Both drugs were well tolerated by the study participants without any significant ocular side effects.
Conclusion
Trehalose-HA was found to be more effective than 0.1% HA eye drops in the management of symptomatic dry eye, as shown by significant reduction in NIBUT, TMH and OSI, when evaluated using non-invasive modalities of dry eye evaluation
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References
Titiyal JS, Falera RC, Kaur M, Sharma V, Sharma N (2018) Prevalence and risk factors of dry eye disease in North India: ocular surface disease index-based cross-sectional hospital study. Indian J Ophthalmol 66(2):207
Gupta N, Prasad I, Jain R, D’Souza P (2010) Estimating the prevalence of dry eye among Indian patients attending a tertiary ophthalmology clinic. Ann Trop Med Parasitol 104(3):247–255
Phadatare SP, Momin M, Nighojkar P, Askarkar S, Singh KK. A Comprehensive Review on Dry Eye Disease: Diagnosis, Medical Management, Recent Developments, and Future Challenges [Internet]. Vol. 2015, Advances in Pharmaceutics. Hindawi; 2015 [cited 2020 Apr 13]. p. e704946. Available from: https://www.hindawi.com/journals/ap/2015/704946/
Hessen M, Akpek EK (2014) Dry eye: an Inflammatory ocular disease. J Ophthalmic Vis Res 9(2):240–250
Akpek EK, Amescua G, Farid M, Garcia-Ferrer FJ, Lin A, Rhee MK et al (2019) Dry eye syndrome preferred practice pattern®. Ophthalmology 126(1):286–334
Ohtake S, Wang YJ (2011) Trehalose: current use and future applications. J Pharm Sci 100:2020–2053. https://doi.org/10.1002/jps.22458
Asiedu K, Kyei S, Mensah SN, Ocansey S, Abu LS, Kyere EA (2016) Ocular surface disease index (OSDI) versus the standard patient evaluation of eye dryness (SPEED): a study of a nonclinical sample. Cornea 35(2):175–180. https://doi.org/10.1097/ICO.0000000000000712 (PMID: 26655485)
Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T (2013) Psychometric properties and validation of the standard patient evaluation of eye dryness questionnaire. Cornea 32(9):1204–1210. https://doi.org/10.1097/ICO.0b013e318294b0c0 (PMID: 23846405)
Benito A, Perez GM, Mirabet S, Vilaseca M, Pujol J, Marín JM, Artal P (2011) Objective optical assessment of tear-film quality dynamics in normal and mildly symptomatic dry eyes. J Cataract Refract Surg 37:1481–1487
Güell JL, Pujol J, Arjona M, Diaz-Douton F, Artal P (2004) Optical quality analysis system; Instrument for objective clinical evaluation of ocular optical quality. J Cataract Refract Surg 30(7):1598–1599. https://doi.org/10.1016/j.jcrs.2004.04.031 (PMID: 15210251)
Bezkorovaina IM, Nakonechnyi DO, Hui Dun Fan, Bezkorovaina AO (2019) Qualitative assessment of the tear film in young adults. J ophthalmol 3:20–5
Tomlinson A, McCann LC, Pearce EI (2010) Comparison of human tear film osmolarity measured by electrical impedance and freezing point depression techniques. Cornea 29(9):1036–1041
Jacobi C, Jacobi A, Kruse FE, Cursiefen C (2011) Tear film osmolarity measurements in dry eye disease using electrical impedance technology. Cornea 30(12):1289–1292
Fondi K, Wozniak PA, Schmidl D, Bata AM, Witkowska KJ, Popa-Cherecheanu A, et al. Effect of Hyaluronic Acid/Trehalose in Two Different Formulations on Signs and Symptoms in Patients with Moderate to Severe Dry Eye Disease [Internet]. Journal of Ophthalmology. 2018 [cited 2019 Jun 10]. Available from: https://www.hindawi.com/journals/joph/2018/4691417/
Latkany R (2008) Dry eyes: etiology and management. Curr Opin Ophthalmol 19:287–291
Tuft S, Lakhani S (2008) Medical management of dry eye disease. Dev Ophthalmol 41:54–74
Lee JH, Ahn HS, Kim EK, Kim TI (2011) Efficacy of sodium hyaluronate and carboxymethylcellulose in treating mild to moderate dry eye disease. Cornea 30:175–179
Johnson ME, Murphy PJ, Boulton M (2008) Carbomer and sodium hyaluronate eyedrops for moderate dry eye treatment. Optom Vis Sci 85(8):750–757. https://doi.org/10.1097/OPX.0b013e318182476c (PMID: 18677239)
Prabhasawat P, Tesavibul N, Kasetsuwan N (2007) Performance profile of sodium hyaluronate in patients with lipid tear deficiency: randomised, double-blind, controlled, exploratory study. Br J Ophthalmol 91(1):47–50. https://doi.org/10.1136/bjo.2006.097691 (PMID: 16973668; PMCID: PMC1857566)
Ohtake S, Wang YJ (2011) Trehalose: current use and future applications. J Pharm Sci 100(6):2020–2053
Chen W, Zhang X, Liu M et al (2009) Trehalose protects against ocular surface disorders in experimental murine dry eye through suppression of apoptosis. Exp Eye Res 89(3):311–318
Hovakimyan M, Ramoth T, Löbler M et al (2012) Evaluation of protective effects of trehalose on desiccation of epithelial cells in three dimensional reconstructed human corneal epithelium. Curr Eye Res 37(11):982–989
Bron AJ, Smith JA, Calonge M (2007) Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop. Ocul Surf 5(2):108–152
Phadatare SP, Momin M, Nighojkar P, Askarkar S, Singh KK (2015) A comprehensive review on dry eye disease: diagnosis, medical management, recent developments, and future challenges. Adv Pharm 2015:704946
Tian L, Qu JH, Zhang XY, Sun XG (2016) Repeatability and reproducibility of noninvasive keratograph 5m measurements in patients with dry eye disease. J Ophthalmol 2016:8013621. https://doi.org/10.1155/2016/8013621
Diaz-Valle D, Arriola-Villalobos P, García-Vidal SE, Sánchez-Pulgarín M, Borrego Sanz L, Gegúndez-Fernández JA et al (2012) Effect of lubricating eyedrops on ocular light scattering as a measure of vision quality in patients with dry eye. J Cataract Refract Surg 38(7):1192–1197
Chiambaretta F, Doan S, Labetoulle M, Rocher N, Fekih LE, Messaoud R, Khairallah M, Baudouin C, HA-trehalose Study Group (2017) A randomized, controlled study of the efficacy and safety of a new eyedrop formulation for moderate to severe dry eye syndrome. Eur J Ophthalmol 27(1):1–9. https://doi.org/10.5301/ejo.5000836 (PMID: 27445067)
Matsuo T (2001) Trehalose protects corneal epithelial cells from death by drying. Br J Ophthalmol 85(5):610–612
Cejková J, Cejka C, Luyckx J (2012) Trehalose treatment accelerates the healing of UVB-irradiated corneas. Comparative immunohistochemical studies on corneal cryostat sections and corneal impression cytology. Histol Histopathol 27(8):1029–1040
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Brar, S., Vanga, H.R. & 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 41, 3349–3359 (2021). https://doi.org/10.1007/s10792-021-01897-9
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DOI: https://doi.org/10.1007/s10792-021-01897-9