Immediate effects of artificial tears with and without preservatives containing hyaluronic acid and carboxymethyl cellulose
Medical hypothesis, discovery & innovation in optometry,
Vol. 4 No. 3 (2023),
3 October 2023
,
Page 102-111
https://doi.org/10.51329/mehdioptometry179
Abstract
Background: Currently, hyaluronic acid (HA) and carboxymethyl cellulose sodium (CMC) are common polymers incorporated in artificial tears (ATs). The aim of the present study was to evaluate the immediate effect of preservative- and preservative-free HA- and CMC-containing ATs on tear-film parameters and determine patient preference after AT instillation.Methods: In this prospective, double-blind, randomized, comparative study, we assessed fluorescein tear break-up time (TBUT), bulbar redness, and tear ferning pattern (TFP) up to 60 min after the instillation of ATs with and without preservatives containing HA and CMC in the recruited participants. To test patient preference, each patient was administered with the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire (OOD4SQ; scale of 0–5) before and 60 min after the instillation of ATs. The selection of 14 descriptive words based the 11-point Ora Calibra™ Drop Comfort Scale (ODCS; scale of 0–10) was administered immediately after instillation of each AT to test the drop comfort score.
Results: We enrolled 200 eyes of 200 patients, including 163 (81.5%) women and 37 (18.5%) men, with a mean (standard deviation) age of 28.38 (5.42) years. Immediately or 5, 15, or 60 min after the instillation, the mean TBUT did not differ by presence of preservatives, HA, or CMC (all P > 0.05). However, it was significantly higher 5-min post-instillation compared to baseline and significantly lower 15- and 60-min post-instillation (all P < 0.05). The mean grade of bulbar redness immediately or 3, 5, 15, or 60 min after instillation did not differ by presence of preservatives for HA or CMC containing ATs (all P < 0.05). It did not differ significantly 3-, 5-, 15-, or 60-min post-instillation compared to baseline (all P > 0.05). The mean drop comfort scale after the instillation of ATs did not differ significantly by presence of preservatives, HA, or CMC (all P < 0.05). Positive descriptive words were selected by a higher proportion of participants in both groups. According to OOD4SQ, the overall discomfort and mean dryness scores improved significantly after instillation of HA-containing ATs (both P < 0.05), while the mean burning sensation, grittiness, and stinging scores remained unchanged (all P > 0.05). The overall discomfort and mean scores for each ocular symptom (P < 0.05), except for stinting (P > 0.05), improved significantly after instillation of CMC-containing ATs. The TFP did not change significantly from baseline to 60 min after the instillation of any AT (P > 0.05).
Conclusions: Both ATs with and without preservatives containing HA and CMC produced positive short-term objective and subjective effects. However, TBUT, TFP, bulbar redness, and patient feedback were comparable for both HA- and CMC-containing ATs. Further trials with longer observation periods or the recruitment of patients with different severities of dry eye could provide more robust and clinically applicable conclusions.
Keywords:
- hyaluronate sodium
- carboxymethyl cellulose
- tear
- patient preferences
- questionnaire
- artificial tear
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10. Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312-34. doi: 10.1016/j.preteyeres.2010.03.001 pmid: 20302969
11. Stanton D, Batich C, Schultz G, Gibson D, Guidi C, Yang Q, et al. A Novel Method to Eliminate Preservatives in Eye Drops. J Ocul Pharmacol Ther. 2018;34(8):584-589. doi: 10.1089/jop.2018.0042 pmid: 30321108
12. Mantelli F, Tranchina L, Lambiase A, Bonini S. Ocular surface damage by ophthalmic compounds. Curr Opin Allergy Clin Immunol. 2011;11(5):464-70. doi: 10.1097/ACI.0b013e32834a95c9 pmid: 21822131
13. Aragona P, Benítez-Del-Castillo JM, Coroneo MT, Mukherji S, Tan J, Vandewalle E, et al. Safety and Efficacy of a Preservative-Free Artificial Tear Containing Carboxymethylcellulose and Hyaluronic Acid for Dry Eye Disease: A Randomized, Controlled, Multicenter 3-Month Study. Clin Ophthalmol. 2020;14:2951-2963. doi: 10.2147/OPTH.S256480 pmid: 33061281
14. Fallacara A, Vertuani S, Panozzo G, Pecorelli A, Valacchi G, Manfredini S. Novel Artificial Tears Containing Cross-Linked Hyaluronic Acid: An In Vitro Re-Epithelialization Study. Molecules. 2017;22(12):2104. doi: 10.3390/molecules22122104 pmid: 29189737
15. Bruix A, Adán A, Casaroli-Marano RP. Eficacia de la carboximetilcelulosa sódica para el tratamiento del síndrome del ojo seco [Efficacy of sodium carboxymethylcellulose in the treatment of dry eye syndrome]. Arch Soc Esp Oftalmol. 2006;81(2):85-92. Spanish. doi: 10.4321/s0365-66912006000200008 pmid: 16511715
16. Sanchez MA, Torralbo-Jimenez P, Giron N, de la Heras B, Herrero Vanrell R, Arriola-Villalobos P, et al. Comparative analysis of carmellose 0.5% versus hyaluronate 0.15% in dry eye: a flow cytometric study. Cornea. 2010;29(2):167-71. doi: 10.1097/ICO.0b013e3181b11648 pmid: 20023577
17. Hilmi MR, Che Azemin MZ, Mohd Kamal K, Mohd Tamrin MI, Abdul Gaffur N, Tengku Sembok TM. Prediction of Changes in Visual Acuity and Contrast Sensitivity Function by Tissue Redness after Pterygium Surgery. Curr Eye Res. 2017;42(6):852-856. doi: 10.1080/02713683.2016.1250277 pmid: 28118054
18. Alanazi SA, El-Hiti GA, Al-Baloud AA, Alfarhan MI, Al-Shahrani A, Albakri AA, et al. Effects of short-term oral vitamin A supplementation on the ocular tear film in patients with dry eye. Clin Ophthalmol. 2019;13:599-604. doi: 10.2147/OPTH.S198349 pmid: 31040640
19. Mohd RH, Che AM, Ithnin MH. Clinical Features of Lid Margin, Meibomian Gland and Tear Film Changes in Patients with Primary Pterygium. J Ophthalmic Res Ocular Care. 2022;5(1):92-6. doi: 10.36959/936/576
20. Ling TE, Othman K, Yan OP, Rashid RA, Tet CM, Yaakob A, et al. Evaluation of Ocular Surface Disease in Asian Patients with Primary Angle Closure. Open Ophthalmol J. 2017;11:31-39. doi: 10.2174/1874364101711010031 pmid: 28400889
21. Tsubota K, Yokoi N, Shimazaki J, Watanabe H, Dogru M, Yamada M, et al; Asia Dry Eye Society. New Perspectives on Dry Eye Definition and Diagnosis: A Consensus Report by the Asia Dry Eye Society. Ocul Surf. 2017;15(1):65-76. doi: 10.1016/j.jtos.2016.09.003 pmid: 27725302
22. Tsubota K. Short Tear Film Breakup Time-Type Dry Eye. Invest Ophthalmol Vis Sci. 2018;59(14):DES64-DES70. doi: 10.1167/iovs.17-23746 pmid: 30481808
23. Köksoy Vay?so?lu S, Öncü E, Dursun Ö, Dinç E. Investigation of Dry Eye Symptoms in Lecturers by Ocular Surface Disease Index. Turk J Ophthalmol. 2019;49(3):142-148. doi: 10.4274/tjo.galenos.2018.67915 pmid: 31245976
24. Versura P, Fresina M, Campos EC. Ocular surface changes over the menstrual cycle in women with and without dry eye. Gynecol Endocrinol. 2007;23(7):385-90. doi: 10.1080/09513590701350390 pmid: 17701769
25. Gibson EJ, Stapleton F, Wolffsohn JS, Golebiowski B. Local synthesis of sex hormones: are there consequences for the ocular surface and dry eye? Br J Ophthalmol. 2017;101(12):1596-1603. doi: 10.1136/bjophthalmol-2017-310610 pmid: 28814411
26. Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015;112(5):71-81; quiz 82. doi: 10.3238/arztebl.2015.0071 pmid: 25686388
27. Foulks GN, Pflugfelder SC. New testing options for diagnosing and grading dry eye disease. Am J Ophthalmol. 2014;157(6):1122-9. doi: 10.1016/j.ajo.2014.03.002 pmid: 24631478
28. Mohd Radzi H, Khairidzan MK, Mohd Zulfaezal CA, Azrin EA. Corneo-pterygium total area measurements utilising image analysis method. J Optom. 2019;12(4):272-277. doi: 10.1016/j.optom.2019.04.001 pmid: 31097348
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