Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study

Moscovici, Bernardo Kaplan; Holzchuh, Ricardo; Sakassegawa-Naves, Fernando Eiji; Hoshino-Ruiz, Diego Ricardo; Albers, Marcos Bottene Villa; Santo, Ruth Miyuki; Hida, Richard Y

doi:10.1016/j.clae.2015.04.004

Cited by 72 publications

(48 citation statements)

References 39 publications

(52 reference statements)

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“…Although some studies have shown mild increase of tear production after topical treatment with tacrolimus, others have shown no change at all. 7,22,40 In the studies that report Schirmer score improvement, some differences with the current and other studies are present, including higher baseline Schirmer scores (>5 mm), different dry eye disease etiologies, or Schirmer assessment without anesthesia. 21,22 In these studies, with higher Schirmer scores at baseline, impairment of the lacrimal unit may have been less severe.…”

Section: Discussioncontrasting

confidence: 57%

A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease

et al. 2016

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Purpose To evaluate the safety and efficacy of topical tacrolimus 0.05% vs. topical methylprednisolone 0.5% in patients with ocular graft-versus-host disease (GVHD). Design Phase I/II, prospective, randomized, double-masked clinical trial. Subjects Eighty eyes from 40 patients diagnosed with chronic ocular GVHD were enrolled. Methods Forty patients with ocular GVHD were randomized; 24 patients were treated with topical tacrolimus 0.05% and 16 patients with topical methylprednisolone 0.5% twice a day for 10 weeks, in addition to continuing their baseline treatment regimen. Main Outcome Measures Safety was evaluated based on occurrence of adverse events. Tolerability was assessed based on subjects’ reports of discomfort after drop instillation. Intraocular pressure (IOP) was monitored. The main efficacy endpoints were: corneal fluorescein staining (CFS), tear break-up time (TBUT), Schirmer test, and expression of the ocular surface inflammatory markers human leukocyte antigen-DR (HLA-DR) and intercellular adhesion molecule-1 (ICAM-1). Symptoms were evaluated using the Ocular Surface Disease Index (OSDI). Results After 10 weeks of treatment, no major adverse events occurred in either treatment group, and there was no significant difference in the composite tolerability scores between the two groups (P=0.06). However, burning sensation was more pronounced with tacrolimus (P=0.002). Topical tacrolimus was more effective than methylprednisolone in reducing the CFS score at week 10 (55% vs. 23% reduction, respectively; P=0.01), and achieved significant improvement in TBUT when compared to baseline (P<0.001). OSDI score reduction achieved statistical significance with tacrolimus (27% reduction; P=0.02) but was marginal with methylprednisolone (32% reduction; P=0.06). ICAM-1 expression by ocular surface epithelium decreased significantly in both groups (tacrolimus P=0.003; methylprednisolone P=0.008), while HLA-DR expression significantly decreased only in the tacrolimus group (P=0.03). Schirmer test scores did not change significantly in either group during the study; IOP increased significantly with methylprednisolone at week 10 (P=0.04). Conclusions Topical tacrolimus 0.05% is safe, generally well tolerated and effective for the treatment of ocular GVHD, without the hypertensive effects of topical corticosteroids.

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Section: Discussioncontrasting

confidence: 57%

A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease

et al. 2016

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“…Similarly, Tacrolimus, which is a calcineurin inhibitor like cyclosporine acts as an immunosuppressive agent and has been found to be a useful anti-inflammatory agent when used topically at a concentration of 0.03% at bid dosing for 3–6 months. 84 Topical azithromycin is being potentially effective and well-tolerated therapy of lid margin disease and meibomian gland dysfunction. 85,86 It is anti-inflammatory, inhibits pro-inflammatory cytokines, and is effective against gram-negative micro-organisms.…”

Section: Approach To Management Of Neuropathic Corneal Painmentioning

confidence: 99%

Understanding Neuropathic Corneal Pain—Gaps and Current Therapeutic Approaches

Goyal

Hamrah

2016

Seminars in Ophthalmology

162

177

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The richly innervated corneal tissue is one of the most powerful pain generator in the body. Corneal neuropathic pain results from dysfunctional nerves causing perceptions such as burning, stinging, eye-ache and pain. Various inflammatory diseases, neurological diseases, and surgical interventions can be the underlying cause of corneal neuropathic pain. Recent efforts have been made by the scientific community to elucidate the pathophysiology and neurobiology of pain resulting from initially protective physiological reflexes, to a more persistent chronic state. The goal of this clinical review is to briefly summarize the pathophysiology of neuropathic corneal pain, describe how to systematically approach the diagnosis of these patients, and finally summarizing our experience with current therapeutic approaches for the treatment of corneal neuropathic pain.

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“…They stated that this new formulation is more effective than 1% methylprednisolone in the management of dry eye. Tacrolimus has been described as an effective drug in the treatment of keratoconjunctivitis, controlling the inflammation in ocular tissues, and improving the tear film stability [Moscovici et al, 2015;Chatterjee and Agrawal, 2016]. Tacrolimus has been described as an effective drug in the treatment of keratoconjunctivitis, controlling the inflammation in ocular tissues, and improving the tear film stability [Moscovici et al, 2015;Chatterjee and Agrawal, 2016].…”

Section: Management Of Delayed Ocular Complications Medical Managementsmentioning

confidence: 99%

“…It is also reported that cationic emulsion of cyclosporine A is very efficient in the management of corneal epithelium lesion [Daull et al, 2016]. Tacrolimus has been described as an effective drug in the treatment of keratoconjunctivitis, controlling the inflammation in ocular tissues, and improving the tear film stability [Moscovici et al, 2015;Chatterjee and Agrawal, 2016]. Fingolimod is a systemic drug in the management of multiple sclerosis, suggested for controlling dry eye disease as well [Xiao et al, 2016].…”

Section: Medical Managementsmentioning

confidence: 99%

Ocular Effects of Sulfur Mustard and Therapeutic Approaches

Panahi

Rajaee

Sahebkar

2017

J of Cellular Biochemistry

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Sulfur mustard (SM) is a strong blistering, highly reactive, lipophilic chemical war agent that causes injury in different organs including the skin, eyes, and respiratory tract. The Eyes are especially susceptible to the consequences of SM poisoning because of the aqueous and mucosal nature of conjunctiva and cornea. DNA alkylation and depletion of glutathione, are the most important mechanisms of SM action in the eye injuries. Acute clinical symptoms are including decrease in visual acuity, dryness, photophobia, blepharospasm, conjunctivitis, and complaints of foreign body sensation and soreness that gradually progress to severe ocular pain. Corneal abrasions, ulcerations, vesication, and perforations are common corneal consequences in SM injured victims. Appearance of chronic symptoms has been reported as chronic inflammation of the corneal and conjunctival vasculature, ischemia, lipid and cholesterol deposition, scarring in cornea, corneal thinning, opacification and perforation of the cornea, limbal stem cell deficiency (LSCD), and neovascularization. Different medical and surgical protocols have been documented in the management of SM-induced ocular injuries, including preservative-free artificial tears, topical steroids and antibiotic, mydriatic, antiglaucoma drops, therapeutic contact lenses, dark glasses and punctal plugs/cauterization, N-acetylcysteine, tarsorrhaphy, amniotic membrane transplantation, stem cell transplantation, and corneal transplantation. New drugs such as resolvin E1, topical form of essential fatty acids, thymosin β4, 43 amino-acid polypeptides, topical form of curcumin, newly formulated artificial tears, diquafosol, rebamipide, tretinoin, and oral uridineseems to be beneficial in the management of ocular lesion associated with sulfur mustard poisoning. Further studies are needed to approve these drugs in SM victims. J. Cell. Biochem. 118: 3549-3560, 2017. © 2017 Wiley Periodicals, Inc.

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Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study

Cited by 72 publications

References 39 publications

A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease

A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease

Understanding Neuropathic Corneal Pain—Gaps and Current Therapeutic Approaches

Ocular Effects of Sulfur Mustard and Therapeutic Approaches

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