Efficacy of Tacrolimus 0.03% Ointment Vs. Olopatadine 0.2% Eye Drops in Vernal Keratoconjunctivitis: A Comparative Study
DOI:
https://doi.org/10.36283/ziun-pjmd14-3/048Keywords:
Vernal Keratoconjunctivitis, patient satisfaction, adverse effects, comparative study, Tacrolimus, OlopatadineAbstract
Background: Vernal keratoconjunctivitis (VKC) is a chronic, vision-threatening eye inflammation typically starting in early childhood and often resolving by puberty, though it can begin earlier and persist into adulthood. This study aimed to evaluate the efficacy and safety of Tacrolimus 0.03% ointment versus Olopatadine 0.2% eye drops in the management of VKC.
Method: A cross-sectional study was conducted at the Department of Ophthalmology, Mardan Medical Complex, Mardan from June 2023 to August 2024, encompassing 288 patients with VKC, who were randomly assigned to receive either Tacrolimus 0.03% ointment (n=144) or Olopatadine 0.2% eye drops (n=144). Demographic data, symptom severity, side effects, and patient satisfaction were assessed. Data were analyzed using SPSS 26.0 with descriptive statistics, t-tests for continuous variables, chi-square for categorical variables, and significance set at P < 0.05.
Results: In a study of 288 VKC patients (mean age 12.6 ± 3.5 years, 73.6% male) treated with Tacrolimus 0.03% ointment or Olopatadine 0.2% drops, Tacrolimus showed greater improvement in pruritus (75.3% vs. 58.3%), photophobia (75.6% vs. 61.0%), and lacrimation (66.7% vs. 51.4%) (P < 0.001), with more complete symptom relief (77.8% vs. 58.3%, P < 0.001) and shorter time to improvement (14.2 vs. 21.6 days, P < 0.001); adverse events were more common with Tacrolimus (63.9% vs. 20.8%, P < 0.001), including burning (33.3%), ocular pain (25.0%), and skin irritation (5.6%), though patient satisfaction was higher (76.4% vs. 59.7%, P = 0.002), confirming its superior efficacy.
Conclusion: Tacrolimus 0.03% ointment exhibits more efficacy than Olopatadine 0.2% eye drops in the treatment of VKC, offering more rapid and significant symptom relief.
References
1. Di Zazzo A, Zhu AY, Nischal K, Fung SS. Vernal keratoconjunctivitis in adults: a narrative review of prevalence, pathogenesis, and management. Front Ophthalmol. 2024 Feb 15;4:1328953. doi:10.3389/fopht.2024.1328953
2. Chauhan G, Mathimaaran S, Chandrasekar A, Chavda VB, Mugundhan R, Srinivasan B, et al. Unpacking VKC: How gender and age shape the clinical picture. Indian J Ophthalmol. 2025 Apr 1;73(4):594–8.
3. Mehta JS, Chen WL, Cheng AC, Cung LX, Dualan IJ, Kekunnaya R, et al. Diagnosis, management, and treatment of vernal keratoconjunctivitis in Asia: recommendations from the management of vernal keratoconjunctivitis in Asia Expert Working Group. Front Med. 2022 Aug 1;9:882240. doi:10.3389/fmed.2022.882240
4. Vichyanond P, Pacharn P, Pleyer U, Leonardi A. Vernal keratoconjunctivitis: a severe allergic eye disease with remodeling changes. Pediatr Allergy Immunol. 2014 Jun;25(4):314–22. doi:10.1111/pai.12131
5. Bielory L, Bonini S. Allergic eye disorders. In: Pawankar R, Canonica GW, Holgate ST, Lockey RF, editors. Inflammatory mechanisms in allergic diseases. 1st ed. Elsevier; 2023 Jan 6. p. 311–23.
6. Baab S, Le PH, Gurnani B, Kinzer EE. Allergic conjunctivitis. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan 26.
7. Chigbu DI, Karbach NJ, Abu SL, Hehar NK. Cytokines in allergic conjunctivitis: unraveling their pathophysiological roles. Life. 2024 Mar 7;14(3):350. doi:10.3390/life14030350
8. Kumagai N, Fukuda K, Fujitsu Y, Yamamoto K, Nishida T. Role of structural cells of the cornea and conjunctiva in the pathogenesis of vernal keratoconjunctivitis. Prog Retin Eye Res. 2006 Mar;25(2):165–87. doi:10.1016/j.preteyeres.2005.11.001
9. Tariq F. Allergic conjunctivitis: review of current types, treatments, and trends. Life. 2024 May 21;14(6):650. doi:10.3390/life14060650
10. Maharana PK, Singhal D, Raj N, Sharma N, Titiyal JS. Role of combined immunomodulator therapy in severe steroid-intolerant vernal keratoconjunctivitis. Eye (Lond). 2021 Mar;35(3):979–87. doi:10.1038/s41433-020-01097-w
11. Kheirkhah A, Zavareh MK, Farzbod F, Mahbod M, Behrouz MJ. Topical 0.005% tacrolimus eye drop for refractory vernal keratoconjunctivitis. Eye (Lond). 2011 Jul;25(7):872–80. doi:10.1038/eye.2011.89
12. Vichyanond P, Tantimongkolsuk C, Dumrongkigchaiporn P, Jirapongsananuruk O, Visitsunthorn N, Kosrirukvongs P. Vernal keratoconjunctivitis: Result of a novel therapy with 0.1% topical ophthalmic FK-506 ointment. J Allergy Clin Immunol. 2004 Feb;113(2):355–8. doi:10.1016/j.jaci.2003.10.051
13. Al-Amri AM, Mirza AG, Al-Hakami AM. Tacrolimus ointment for treatment of vernal keratoconjunctivitis. Middle East Afr J Ophthalmol. 2016 Jan;23(1):135–8. doi:10.4103/0974-9233.171827
14. Feizi S, Javadi MA, Alemzadeh-Ansari M, Arabi A, Shahraki T, Kheirkhah A. Management of corneal complications in vernal keratoconjunctivitis: A review. Ocul Surf. 2021 Jan;19:282–9. doi:10.1016/j.jtos.2020.10.004
15. Meena M, Jagrwal S, Meena R, Meena MK. Study the efficacy and safety of tacrolimus 0.03% skin cream, in moderate to severe vernal keratoconjunctivitis in paediatric age group. Eur J Mol Clin Med. 2021 Jun 22;8(4):1677–85.
16. Sultan M, Rizvi F, Kamil Z, Ali A, Shaikh A, Amin S. Efficacy of supratarsal triamcinolone injection in the treatment of recalcitrant vernal keratoconjunctivitis. Pak J Pharm Sci. 2025 Mar 1;38(2).
17. Senthil S, Rao HL, Ali MH, Krishnamurthy R, Dikshit S, Choudhari N, et al. Long-term outcomes and risk factors for failure of glaucoma filtering surgery in eyes with vernal keratoconjunctivitis and steroid-induced glaucoma. Indian J Ophthalmol. 2022 Mar 1;70(3):820–5. doi:10.4103/ijo.IJO_2141_21
18. Mehta JS, Chen WL, Cheng AC, Cung LX, Dualan IJ, Kekunnaya R, et al. Diagnosis, management, and treatment of vernal keratoconjunctivitis in Asia: recommendations from the management of vernal keratoconjunctivitis in Asia Expert Working Group. Front Med. 2022 Aug 1;9:882240. doi:10.3389/fmed.2022.882240
19. Fukasawa T, Yoshizaki-Ogawa A, Enomoto A, Miyagawa K, Sato S, Yoshizaki A. Pharmacotherapy of itch—antihistamines and histamine receptors as G protein-coupled receptors. Int J Mol Sci. 2022 Jun 13;23(12):6579. doi:10.3390/ijms23126579
20. Bharali A, Deka B, Sarma H, Sarma S, Ahmed A, Bhattacharjee B, et al. Integrating recommendations to improve treatment outcomes in the clinical management of allergic conjunctivitis. Pharm Biosci J. 2021 May 11:22–40.
21. Koh K, Jun I, Kim TI, Kim EK, Seo KY. Long-term results of topical 0.02% tacrolimus ointment for refractory ocular surface inflammation in pediatric patients. BMC Ophthalmol. 2021 Jun 5;21(1):247. doi:10.1186/s12886-021-01978-3
22. Tajbakhsh Z. Dendritic cells in ocular allergy [dissertation]. Sydney (AU): University of New South Wales; 2020.
23. Saha BC, Kumari R, Ambasta A. Comparison of efficacy and safety of 0.03% and 0.1% tacrolimus ointment in children with vernal keratoconjunctivitis. Ther Adv Ophthalmol. 2023 May;15:25158414231173532. doi:10.1177/25158414231173532
24. Dowd M, Shary N, Wang M, Colegio OR. Direct dermatologic side effects of immunosuppressive therapy in solid organ transplant recipients. In: Colegio OR, editor. Dermatology and Solid Organ Transplantation. Boca Raton (FL): CRC Press; 2021 Aug 15. p. 247–60.
25. Singh RK. A comparative clinical study regarding efficacy of olopatadine (0.1%) versus tacrolimus (0.03%) in vernal keratoconjunctivitis (VKC). EyeQuest. 2021 May 1;46(1):53–8.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Pakistan Journal of Medicine and Dentistry
This work is licensed under a Creative Commons Attribution 4.0 International License.
This is an open-access article distributed under the terms of the CreativeCommons Attribution License (CC BY) 4.0 https://creativecommons.org/licenses/by/4.0/
Metrics
How to Cite
