Evaluation of Pimecrolimus 1%, 0.3% and 0.1% Compared to vehicle for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model

Ousler, George W; Haque, Reza; Weichselberger, Andreas; Yannoulis, N.C.; Abelson, Mark B.

doi:10.1016/s1542-0124(12)70518-9

Cited by 4 publications

(4 citation statements)

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“…The low success rate may be due to the multitude of potential confounders, including clinical trial length (in relation to time taken to reverse end points), numerous environmental factors, heterogeneity in study populations (e.g., age, gender, comorbidities), and the heterogeneity of DED itself (in terms of causes, symptoms, and clinical manifestations). While some trials of potential therapies (such as rebamipide 350 and pimecrolimus 351 ) have ended quietly with little explanation, the results of other failed studies have highlighted overarching issues that plague clinical trials for DED.…”

Section: Iva3 Reasons For Failure In Clinical Trials For Dedmentioning

confidence: 99%

Report of the Inaugural Meeting of the TFOS i2 = initiating innovation Series: Targeting the Unmet Need for Dry Eye Treatment

et al. 2016

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On March 21, 2015, a meeting was held in London, United Kingdom, to address the progress in targeting the unmet need for dry eye disease (DED) treatment. The meeting, which launched the i(2) = initiating innovation series, was sponsored by the Tear Film & Ocular Surface Society (TFOS; www.TearFilm.org) and supported by Dompé. The TFOS i(2) meeting was designed to review advances in the understanding of DED since publication of the 2007 TFOS International Dry Eye WorkShop (DEWS) report, and to help launch the highly anticipated sequel, DEWS II. The meeting was structured to discuss the scope of the DED problem, to review the clinical challenges of DED, and to consider the treatment challenges of DED. This article provides a synopsis of the presentations of this TFOS i(2) meeting.

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Section: Iva3 Reasons For Failure In Clinical Trials For Dedmentioning

confidence: 99%

Report of the Inaugural Meeting of the TFOS i2 = initiating innovation Series: Targeting the Unmet Need for Dry Eye Treatment

et al. 2016

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“…Calcineurin inhibitors, such as tacrolimus or pimecrolimus, in their ophthalmologic preparations seem to be potentially useful for the treatment of KCS, at least in patients with unsatisfying response to cyclosporine A [Nell et al 2005;Ousler et al 2005].…”

Section: Therapeutic Advances In Musculoskeletal Disease 2 (3)mentioning

confidence: 99%

Treating Sjögren’s syndrome: insights for the clinician

Vitali¹,

Palombi²,

Cataleta³

2010

Therapeutic Advances in Musculoskeletal

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Sjögren's syndrome (SS) is a systemic autoimmune disease that affects the exocrine glands, mainly the salivary and lachrymal glands, with consequent persistent dryness of the mouth and eyes. In addition to the clinical manifestations related to the exocrine gland involvement, a consistent prevalence of patients may present systemic manifestations. Some of these can be ascribed to the periepithelial extension of lymphocytic infiltration whilst others are determined by an immunomediated process affecting small-or medium-size vessels. While the use of tear and saliva substitutes and local or systemic stimulation of residual secretions represent the mainstays of the therapy of sicca component, different immunomodulating or immunosuppressive agents are usually required to treat extraglandular features, similarly to what happens in other connective tissue diseases. In the last few years, the advancement in the understanding the pathogenetic mechanisms of this disorder and the availability of new biologic target therapies seem to offer completely new therapeutic options. The use of B cell depleting or modulating therapies has achieved promising results.

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“…It is currently used both to screen patients for inclusion into clinical trials and is a way of producing standardized stress to the ocular surface, providing a precise methodology for evaluating a relative effectiveness of both prophylactic and therapeutic agents. [9][10][11][12] The CAE provides reproducible environmental challenges by controlling humidity (,10%), temperature (76 6 6°F), airflow (constant, nonturbulent), lighting conditions, and visual tasking (television or PC use), and can significantly increase blink rate in patients with dry eye. 13 Changes in blink rate from environmental conditions may be attributed to a compensatory mechanism triggered by increased discomfort.…”

Section: Environmental Conditionsmentioning

confidence: 99%

The Ocular Protection Index

Ousler

Hagberg

Schindelar

et al. 2008

Cornea

114

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The interaction of the time between blinks, or the interblink interval (IBI), and tear film breakup time (TFBUT) helps to regulate the integrity of the ocular surface. A protected surface exists when the TFBUT matches or exceeds the IBI. In contrast, an unprotected surface exists when TFBUT is less than the IBI. This is clinically relevant because repeated intermittent exposure of a tear film-deficient cornea can lead to ocular discomfort and the development of clinical signs, such as keratitis and redness. The relationship between TFBUT and IBI has been quantified by the Ocular Protection Index (OPI), which is calculated by dividing TFBUT by IBI. If the OPI is <1.0, the patient has an exposed ocular surface, putting them at risk for the development of the signs and symptoms of dry eye, whereas if the OPI is >or=1.0, the patient's ocular surface is tear film protected. The OPI has proven to be useful in assessing the factors that may cause or exacerbate dry eye. This review discusses the development and use of the OPI model, its relationship to dry eye, and factors that are known to alter blink rate and tear film integrity.

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Evaluation of Pimecrolimus 1%, 0.3% and 0.1% Compared to vehicle for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model

Cited by 4 publications

References 0 publications

Report of the Inaugural Meeting of the TFOS i2 = initiating innovation Series: Targeting the Unmet Need for Dry Eye Treatment

Report of the Inaugural Meeting of the TFOS i2 = initiating innovation Series: Targeting the Unmet Need for Dry Eye Treatment

Treating Sjögren’s syndrome: insights for the clinician

The Ocular Protection Index

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