Rationale and Background. Responding to the Government’s Payroll Giving consultation, a large number of respondents made requests to institute a Service Level Agreement regulating the work between Payroll Giving Agencies and the wider charity sector. Another request coming from this consultation was for more transparency around the process as well as disbursement reports in a standardised format. It was suggested that a Service Level Agreement could also be used to increase the transparency and information flow between charities and Payroll Giving Agencies. In the government’s response document there was a commitment to pursue an agreement that could provide greater clarity on how well Payroll giving operates. Subsequently a number of meetings were held between the various parties resulting in this document. This document aims to address these points, with the overriding principle to see an increase in take-up of Payroll Giving and donations being received by charities. To better reflect the voluntary nature of this agreement it has been framed as a Memorandum of Understanding. Intent of this document This voluntary agreement has been drawn up following extensive contacts between Government, Payroll Giving Agencies and representatives from the charity sector. Whilst not a legally binding document its authority is derived from its endorsement by the participants. Payroll Giving Agencies, the Government and charities agree to work together constructively in our complementary roles. The parties here would welcome further participants in this agreement, including from charities, Payroll Giving Agencies, both existing and new and their service delivery partners. As Payroll Giving Agencies update and invest in their systems and processes, even more improvements may become possible. To that end the participants may wish to review and amend some aspects of this agreement, in the same manner of consensus and constructive engagement. This endorsement represents a concrete expression of goodwill and partnership between Payroll Giving Agencies and the wider charity sector. Disbursement Reports Disbursement reports are provided by Payroll Giving Agencies to charities that request, and in most cases, pay for them. They give detailed information on individual donations. Currently charities may receive reports from multiple Payroll Giving Agencies which, whilst providing common information, are formatted and presented differently. During the consultation, a proposal was made to standardise the for...
Rationale and Background. It is estimated that soft contact lenses account for over 90% of lens fits. Furthermore, it was reported that almost 32% of soft contact lenses were prescribed in a daily disposable modality. PRECISION1 is a new daily disposable silicone hydrogel contact lens with a material that combines high oxygen transmissibility with a low modulus of elasticity. PRECISION1 contact lenses are intended for the optical correction of refractive ametropia in persons with nondiseased eyes requiring subjects to wear spectacles for vision correction. The unique properties of PRECISION1 contact lenses provide precise vision, long lasting comfort, and excellent handling.
Rationale and Background. Increasing numbers of contact lens wearers use digital devices for prolonged and demanding periods throughout the day and suffer from Digital Eye Fatigue (DEF). Near universal use of digital devices, and time spent on them, is becoming a growing short-term problem and a concern for long-term vision health. Currently, there are few products addressing DEF, and mostly in spectacle form. The targeted population is pre-presbyopic (< 40 years of age) with heavier usage of digital devices.
Rationale and Background. The objective of the DACP Digital project is to introduce a modification to the DAILIES AquaComfort Plus Contact Lens (DACP) family, This clinical evaluation is a performance verification trial The primary and secondary endpoints were selected to fulfil the primary and secondary objectives of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments.
Rationale and Background. The first clinical results of the multifocal intraocular lenses were reported in the United States in 1987. The first Japanese clinical study was performed and reported in the early 1990’s 1). In general, multifocal intraocular lenses are roughly divided into diffractive and refractive types. Diffractive lenses are structured to separate incident light energy to far and near visions, while refractive lenses have an optical zone structure consisting of far and near vision zones arranged in an alternate, concentric manner 2). Since the diffractive multifocal intraocular lens product, “Alcon® AcrySof® ReSTOR® Single Piece” (medical device approval number: 21900BZX00605000, Alcon Japan Ltd.) was first approved in 2007, various multifocal intraocular lenses have been developed in Japan. As opposed to monofocal intraocular lenses, intraocular lenses with 2 or more focuses are collectively called multifocal intraocular lenses. Actually bifocal intraocular lenses focusing on far and intermediate or near objects account for most of multifocal intraocular lenses in Japan, however three trifocal intraocular lenses, “Alcon Acrysof IQ PanOptix Single Piece (medical device approval number: 23100BZX00042000, Alcon Japan Ltd.)” and “Alcon Acrysof IQ PanOptix Toric Single Piece (medical device approval number: 23100BZX00043000, Alcon Japan Ltd.)”, focusing on far, intermediate, and near objects were approved in 2019. The AcrySof IQ PanOptix Toric IOL is a diffractive multifocal lens with a toric optic to correct pre-existing corneal astigmatism. The ACRYSOF IQ PanOptix Toric IOL is commercially available in 4 cylinder powers to reduce pre-existing corneal astigmatism (ACRYSOF IQ PanOptix Toric IOL TFNT30 - TFNT60), but the TFNT20, having lower cylinder power than approved products, has not been approved. Levels of astigmatism 0.5 D to 1.0 D are estimated to represent 35.6% of all cataract cases in Japan 3). For those patients, a lack of astigmatism correction can limit their desired outcome of visual acuity. Correcting astigmatism concurrently during phacoemulsification cataract surgery eliminates the need for additional surgical procedures, such as excimer laser keratectomy and limbal and corneal relaxing incision techniques. For example, the excimer laser can be cost prohibitive 4) and limbal and corneal relaxation incision can have less predictable results compared to Toric IOL options 4) 5) 6) 7) 8). The effect of astigmatism on the visual acuity of a multifocal intrao...
Rationale and Background. Presbyopia is an age-related vision condition in which the crystalline lens gradually loses its ability to change shape when acted upon by the ciliary muscle. It typically becomes evident by 40 to 45 years of age and it is expressed by a reduction in the ability to define letters or objects at near distance. The condition can be corrected by the use of single-vision or bifocal spectacles, PALs, or MF contact lenses. Alcon manufactures three MF contact lenses (lotrafilcon B, nelfilcon A, and delefilcon A) with the same Precision Profile optical design that allows for the same fitting process with all three lenses. The AOHG MF soft contact lenses are made of a lens material that is approximately 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface-treated. These lenses may be prescribed for daily wear or extended wear for up to 6 nights of continuous wear with removal for disposal, or cleaning and disinfection prior to reinsertion, as recommended by the eye care professional. The DACP MF daily disposable, soft contact lens is made up of 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). DT1 MF (delefilcon A) daily disposable, soft contact lenses feature a unique water gradient composition from a silicone-rich highly breathable core (33% water) to an ultrasoft hydrophilic surface gel (> 80% water at the lens surface). The goal of this study is to demonstrate seamless transition vision in presbyopes using Precision Profile Design MF contact lenses.
Rationale and Background. The Lender has entered into the Loan Agreement to optimise returns on its available funds. This is consistent with the overall objective of the Company and its subsidiaries (the “Group”) of enhancing shareholder value. The Borrower is a Singapore incorporated investment holding company and is the sole shareholder of Pacific Star Development Pte. Ltd (“PSD”), a property development company with a special focus to source, evaluate, invest and proactively commit to the planning, development and management of prime development projects in the Asia region. PSD has ownership interests in various property assets in Malaysia and Thailand. Pursuant to the Loan Agreement, the Lender will disburse a loan of US$7,000,000 (“Loan”) to the Borrower on 31 May 2016 (the “Drawdown Date”).
Rationale and Background. It is estimated that soft contact lenses account for over 90% of lens fits. Moreover, almost 32% of soft contact lenses were prescribed in a daily disposable modality. DT1 contact lenses were introduced as a unique dual technology that combines a low water content silicone hydrogel core, to achieve optimal oxygen supply, with a high water content hydrogel surface to provide a highly lubricious, wettable lens. Previous studies support the hypothesis that Water Gradient Technology in DT1 lenses produces superior clinical performance and subjective acceptance.
Rationale and Background. Huntington’s disease (HD) is caused by a dominant genetic defect resulting in the cellular expression of the toxic mutant huntingtin protein (mtHtt)mtHtt misfolds, oligomerizes and becomes insoluble, forming intracellular aggregates which are a pathologic hallmark of the disease. Most evidence has indicated that toxicity resides in the soluble mtHtt protein or its cleavage products, which unleash a slow cascade of pathogenic biology leading to gradual neuronal dysfunction and death (1-11). We (12, 13) have shown that huntingtin coordinates copper (Cu2+) in a redox active manner that promotes the oligomerization of soluble huntingtin by cross-linking specific N-terminus cysteine residues. This cross-linking promotes accumulation of Huntington oligomers and promotes toxicity while its prevention enhances the metabolism of mutant huntingtin, reduces accumulation, and is neuroprotective. We hypothesize that PBT2 could be neuroprotective for HD by preventing huntingtin oligomerization and promoting its clearance which is suggested by the existing preclinical studies in HD transgenic mice. Together with Xxxxx et al (14,15) we have described a cell-based multiplex assay able to measure soluble mtHtt using time-resolved Xxxxxxx Resonance Energy Transfer (trFRET) for use in biological and clinical tissues, detecting simultaneously mtHtt and its relative ratio to total huntingtin (tHtt). In preliminary studies, we have found the assay (Homogeneous trFRET or HTRF) to be sensitive and specific for soluble mtHtt in tissues and blood from HD mouse models, and in postmortem tissue and blood samples from HD subjects. We further optimized the assay using human brain lysates from healthy controls and HD subjects, validated it and created a Standard Operating Procedure (SOP) that complies with Good Laboratory Practice Standards (GLP). The assay is highly specific, robust and has good technical and biological reproducibility. Using the GLP’ SOP we detected a significant increase in the mt/tHt ratio in HD versus control subjects (16). This assay could be an ideal pharmacodynamic measure of mtHtt for treatments modulating it, as we expect of PBT2.
Rationale and Background. A. Describe the purpose of the study.
