Efficacy and Safety of Pilocarpine Eye Drops Combinations for Treating Presbyopia in a Thai Population: A Randomized Crossover Trial

Authors

  • Thammanoon Surachatkumtonekul Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • Pinpilai Jutasompakorn Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
  • Anchalika Klinniyom Pharmacy Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand
  • Wasawat Sermsripong Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • Kiatthida Hokierti Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • Prapasson Sangsre Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • Ketchanya Rungsiri Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

DOI:

https://doi.org/10.33192/smj.v76i10.268911

Keywords:

Presbyopia, pilocarpine, brimonidine, refractive errors

Abstract

Objective: This study aimed to assess and compare the effectiveness and side effects of various concentrations of pilocarpine eye drops (1.5%, 1.25%, and 1%), with and without 0.1% brimonidine, in treating presbyopia, specifically in a Thai population.

Materials and Methods: A prospective, randomized, double-blinded, and crossover trial was conducted at Siriraj Hospital from August 2022 to April 2023. The study included emmetropic individuals aged 40 to 60 with presbyopia (near visual acuity not exceeding J1+) and refractive errors within +/- 0.5D. The ten subjects were assigned randomly to 6 groups for the different concentrations and type of eyedrops using a computer-generated systematic randomization to receive 1.5%, 1.25%, and 1% pilocarpine with and without 0.1% brimonidine. And visual outcomes including visual acuity at distance and near were measured at 2, 4, and 6 hours post-application, with adverse effects monitored. Primary outcome was visual acuity at near after applied topical eye drops.

Results: Among the 10 participants (30% male, median age 46.5 years old), 1.25% pilocarpine and combined 1.25% pilocarpine + 0.1% brimonidine significantly improved near visual acuity at all time points (statistically significant with Bonferroni correction). Adverse effects, such as dry eye and irritation, were more common with 1.5% pilocarpine + 0.1% brimonidine.

Conclusion: In this preliminary study, 1.25% pilocarpine and 1.25% pilocarpine + 0.1% brimonidine showed promise in effectively treating presbyopia in the Thai study population, with acceptable side effect rates. Further research with larger sample sizes is needed to confirm these findings and provide more robust insights into presbyopia management in the Asian demographic.

References

Weale RA. Epidemiology of refractive errors and presbyopia. Surv Ophthalmol. 2003;48(5):515-43.

Duane A. Normal values of the accommodation at all ages. JAMA. 1912;LIX(12):1010–3.

Abdelkader A, Kaufman HE. Clinical outcomes of combined versus separate carbachol and brimonidine drops in correcting presbyopia. Eye Vis (Lond). 2016;3:31.

Fricke TR, Tahhan N, Resnikoff S, Papas E, Burnett A, Ho SM, et al. Global prevalence of presbyopia and vision impairment from uncorrected presbyopia. Ophthalmology. 2018;125(10):1492-9.

Understanding presbyopia’s symptoms, causes and treatments. Versant Health website. Accessed April 21, 2022. https://versanthealth.com/blog/understanding-presbyopias-symptoms-causes-and-treatments

Berdahl J, Bala C, Dhariwal M, Lemp-Hull J, Thakker D, Jawla S. Patient and Economic Burden of Presbyopia: A Systematic Literature Review. Clin Ophthalmol. 2020;14:3439-50.

Goertz AD, Stewart WC, Burns WR, Stewart JA, Nelson LA. Review of the impact of presbyopia on quality of life in the developing and developed world. Acta Ophthalmol. 2013;92(6):497-500.

Frick KD, Joy SM, Wilson DA, Naidoo KS, Holden BA. The global burden of potential productivity loss from uncorrected presbyopia. Ophthalmology. 2015;122(80):1706-10.

Arlt E, Krall E, Moussa S, Grabner G, Dexl A. Implantable inlay devices for presbyopia: the evidence to date. Clin Ophthalmol. 2015:14;(9):129-37

Vuity. Allergan website. Accessed April 21, 2022. Available from: https://www.vuity.com/

Sneader W. Drug Discovery: A History. John Wiley & Sons. 1st ed. Chichester: Antony Rowe Ltd. 98-9.

Rosin A. "[Pilocarpine. A miotic of choice in the treatment of glaucoma has passed 110 years of use]". Oftalmologia (in Romanian). 1991;35(1):53-5.

Gupta SK, Niranjan D G, Agrawal SS, Srivastava S, Saxena R. Recent advances in pharmacotherapy of glaucoma. Indian J Pharmacol. 2008;40(5):197-208.

Price FW Jr, Hom M, Moshirfar M, Evans D, Liu H, Penzner J, et al. Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia: Two Randomized Phase 2 Studies. Ophthalmol Sci. 2021;1(4):100065.

Tucker J, Charman WN. The depth-of-focus of the human eye for Snellen letters. Am J Optom Physiol Opt. 1975;52:3e21.

Giovannitti JA Jr, Thoms SM, Crawford JJ. Alpha-2 adrenergic receptor agonists: a review of current clinical applications. Anesth Prog. 2015;62(1):31-9.

Kato CO, Shimizu K, Kamiya K, Ishikawa H, Igarashi A. Effects of brimonidine tartrate 0.1% ophthalmic solution on the pupil, refraction, and light reflex. Sci Rep. 2018;8(1):9003.

Lyons JS, Krohn DL. Pilocarpine uptake by pigmented uveal tissue. Am J Ophthalmol 1973;75:885‐8.

Lay M, Wickware E, Rosenfield M. Visual acuity and contrast sensitivity. In: Optometry: Science, Techniques and Clinical Management, 2nd eds. In: Rosenfield M, Logan N & Edwards K(eds), Butterworth‐Heinemann: Oxford, 2009.p.178-9.

Charman WN, Tucker J. The depth‐of‐focus of the human eye for Snellen letters. Am J Optom Physiol Opt. 1975;52:3-21.

Kim WS, Park IK, Chun YS. Quantitative analysis of functional changes caused by pinhole glasses. Invest Ophthalmol Vis Sci. 2014;55:6679-85.

Li G, Farsiu S, Chiu SJ, Gonzalez P, Lütjen-Drecoll E, Overby DR, Stamer WD. Pilocarpine-induced dilation of Schlemm's canal and prevention of lumen collapse at elevated intraocular pressures in living mice visualized by OCT. Invest Ophthalmol Vis Sci. 2014;55(6):3737-46.

Team C. by Mimso. Pilocarpine, Pilocarpine: Indication, Dosage, Side Effect, PrecautionMIMS Thailand. Available from: https://www.mims.com/thailand/drug/info/pilocarpine?mtype=generic#:~:text=Onset%3A%20Ophth%3A%20miosis%3A%2010,reduction%3A%204-12%20hr (Accessed: 26 June 2024). )

Orasis Pharmaceuticals announces FDA approval of QLOSITM (Pilocarpine Hydrochloride Ophthalmic Solution) 0.4% for the treatment of Presbyopia. Orasis. October 18, 2023. Accessed October 18, 2023. Available from: https://www.orasis-pharma.com/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia/.

Iapoce C. FDA approves Pilocarpine HCI ophthalmic solution 1.25% for treatment of Presbyopia. HCP Live. November 1, 2021. Accessed October 18, 2023. Available from: https://www.hcplive.com/view/fda-approves-pilocarpine-hci-ophthalmic-solution-treatment-presbyopia.

Published

01-10-2024

How to Cite

Surachatkumtonekul, T. ., Jutasompakorn, P. ., Klinniyom, A. ., Sermsripong, W. ., Hokierti, K. ., Sangsre, P. ., & Rungsiri, K. . (2024). Efficacy and Safety of Pilocarpine Eye Drops Combinations for Treating Presbyopia in a Thai Population: A Randomized Crossover Trial. Siriraj Medical Journal, 76(10), 718–726. https://doi.org/10.33192/smj.v76i10.268911

Issue

Section

Original Article

Categories