Effects of botulinum toxin type A on the treatment of dry eye disease and tear cytokines

Choi, Min Gyu; Yeo, Joon Hyung; Kang, Jeong Woo; Chun, Yeoun Sook; Lee, Jeong Kyu; Kim, Jae Chan

doi:10.1007/s00417-018-4194-3

Cited by 13 publications

(7 citation statements)

References 27 publications

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“…Finally, 56 articles were included in the meta-analysis. As a placebo, the studies included in this meta-analysis used saline [ 30 , 33 , 34 , 37 , 45 , 47 , 48 , 53 , 57 , 71 , 72 , 74 , 77 ] or balanced salt solution [ 35 ], vehicle drops [ 29 , 43 , 50 , 52 , 56 , 61 , 66 – 68 , 80 ], artificial tears [ 81 ], sham pulsed light treatment [ 55 , 78 ], sham acupuncture [ 92 ], an ophthalmic solution containing base only [ 36 ], oral vitamin E [ 39 ], olive oil [ 7 , 42 , 44 , 51 , 70 , 75 , 83 ], sunflower oil [ 59 , 85 ], safflower oil [ 84 ], wheat germ oil [ 65 ], corn oil [ 54 ], palm and coconut oil [ 62 , 63 ], medium-chain fatty acids [ 60 ], or tablets without the active ingredient with the same appearance as the active treatment [ 40 , 46 , 49 , 58 , 69 , 79 ], placebo beverage with a similar texture, flavour, and taste as the active agent [ 31 ],1000 IU of vitamin A in a study using 100,000 IU of vitamin A as active treatment [ 76 ], or the placebo was not exactly specified [ 9 , 41 , 73 , 82 ]. Therefore, the choice of placebo was heterogenous.…”

Section: Resultsmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

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Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis

et al. 2022

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Background The efficacy of various common treatment options for dry eye disease (DED) has been investigated against placebo. However, the potential beneficial effect of placebo in the management of DED is still unclear. Aim This meta-analysis investigated the impact of placebo administration in DED in Ocular Surface Disease Index (OSDI), Schirmer I test (SIT), tear breakup time (TBUT), corneal staining, and complications. Method This meta-analysis and systematic review was conducted according to the 2020 PRISMA guidelines. In March 2022, Pubmed, Web of Science, Google Scholar, and Embase were accessed. All the randomised clinical trials which investigated any active treatment against a placebo control group were considered. The following data were extracted at baseline and at last follow-up: Ocular Surface Disease Index (OSDI), tear breakup time test (TBUT), Schirmer I test (SIT), corneal staining. Results Data from 56 studies (12,205 patients) were retrieved. Placebo administration is not effective in improving TBUT (P = 0.3), OSDI (P = 0.2), SIT (P = 0.1) and corneal staining (P = 0.1) from baseline to last follow-up. Active treatment led to a higher TBUT and SIT compared to placebo administration (P < 0.0001). The active treatment resulted in a lower OSDI compared to placebo administration (P = 0.0005). Five studies reported data on the corneal staining. No difference was found between placebo administration and active treatment (P = 0.8). Conclusion Placebo administration does not impact symptoms of DED and can be successfully employed to evaluate the efficacy of active treatments.

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Section: Resultsmentioning

confidence: 99%

Section: Study Selectionmentioning

confidence: 99%

Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis

et al. 2022

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“…[ 65 ] Serotonin, known to be activated by inflammation, might play a role in inducing corneal hypersensitivity in DED. [ 81 ] Increased NGF has been shown to play a protective role in DED by improving tear secretion and increasing epithelial cell layer integrity, whereas reduced CGRP is reported to be associated with lacrimal gland dysfunction. [ 11 ] Four out of five publications showed increased NGF levels [ Table 2 and Fig.…”

Section: Neurotrophic Factors and Neuropeptidesmentioning

confidence: 99%

Tear biomarkers in dry eye disease: Progress in the last decade

Kumar

Machiraju

Narasimhan

et al. 2023

Indian Journal of Ophthalmology

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Dry eye disease (DED) is a commonly occurring, multifactorial disease characterized by reduced tear film stability and hyperosmolarity at the ocular surface, leading to discomfort and visual compromise. DED is driven by chronic inflammation and its pathogenesis involves multiple ocular surface structures such as the cornea, conjunctiva, lacrimal glands, and meibomian glands. The tear film secretion and its composition are regulated by the ocular surface in orchestration with the environment and bodily cues. Thus, any dysregulation in ocular surface homeostasis causes an increase in tear break-up time (TBUT), osmolarity changes, and reduction in tear film volume, all of which are indicators of DED. Tear film abnormalities are perpetuated by underlying inflammatory signaling and secretion of inflammatory factors, leading to the recruitment of immune cells and clinical pathology. Tear-soluble factors such as cytokines and chemokines are the best surrogate markers of disease severity and can also drive the altered profile of ocular surface cells contributing to the disease. Soluble factors can thus help in disease classification and planning treatment strategies. Our analysis suggests increased levels of cytokines namely interleukin-1β (IL-1β), IL-2, IL-4, IL-6, IL-9, IL-12, IL-17A, interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α); chemokines (CCL2, CCL3, CCL4, CXCL8); MMP-9, FGF, VEGF-A; soluble receptors (sICAM-1, sTNFR1), neurotrophic factors (NGF, substance P, serotonin) and IL1RA and reduced levels of IL-7, IL-17F, CXCL1, CXCL10, EGF and lactoferrin in DED. Due to the non-invasive sample collection and ease of quantitively measuring soluble factors, tears are one of the best-studied biological samples to molecularly stratify DED patients and monitor their response to therapy. In this review, we evaluate and summarize the soluble factors profiles in DED patients from the studies conducted over the past decade and across various patient groups and etiologies. The use of biomarker testing in clinical settings will aid in the advancement of personalized medicine and represents the next step in managing DED.

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“…There is scientific evidence that botulinum toxin type A (BTX-A) can be used either for increasing tear production by lacrimal gland or for impairing drainage because of the blockage of the lacrimal drainage system through paralysis of the orbicularis oculi muscle or decreasing blepharospasm and loss of the tear film. 124 In a recent double-blind RCT, BTX-A (2.5 IU/0.05 mL) or normal saline was injected to the medial part of both upper and lower eyelids of patients with intractable DED. 124 One month after injection, improvement in symptoms, TBUT, Schirmer test, staining, frequency of lubricants used, and tear levels of matrix metalloproteinase-9 and serotonin were significantly better in the BTX-A group.…”

Section: Botulinum Toxinmentioning

confidence: 99%

“…124 In a recent double-blind RCT, BTX-A (2.5 IU/0.05 mL) or normal saline was injected to the medial part of both upper and lower eyelids of patients with intractable DED. 124 One month after injection, improvement in symptoms, TBUT, Schirmer test, staining, frequency of lubricants used, and tear levels of matrix metalloproteinase-9 and serotonin were significantly better in the BTX-A group.…”

Section: Botulinum Toxinmentioning

confidence: 99%

Update on Dry Eye Disease Treatment: Evidence From Randomized Controlled Trials

Ucakhan,

Celik-Buyuktepe,

Yang

et al. 2023

Eye &Amp; Contact Lens: Science &Amp; Clinical Practice

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Although the ultimate goal of dry eye disease (DED) management is to restore the ocular surface and tear film homeostasis and address any accompanying symptoms, addressing this is not an easy task. Despite the wide range of current treatment modalities targeting multiple aspects of DED, the available DED management literature is quite heterogeneous, rendering evaluation or comparison of treatment outcomes hard or almost impossible. There is still a shortage of well-designed, large-scale, nonsponsored, randomized, controlled trials (RCTs) evaluating long-term safety and efficacy of many targeted therapies individually or used in combination, in the treatment of identified subgroups of patients with DED. This review focuses on the treatment modalities in DED management and aims to reveal the current evidence available as deduced from the outcomes of RCTs.

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Effects of botulinum toxin type A on the treatment of dry eye disease and tear cytokines

Cited by 13 publications

References 27 publications

Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis

Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis

Tear biomarkers in dry eye disease: Progress in the last decade

Update on Dry Eye Disease Treatment: Evidence From Randomized Controlled Trials

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