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. 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 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 format of these reports to reduce the costs 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. 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. A. Describe the purpose of the study.
B. State the hypotheses.
C. Describe the research question(s).
D. List no more than five relevant studies published on this topic.
Rationale and Background. Daily disposable (DD) lenses are worn for a full day, during waking hours, and then discarded after usage. This type of contact lens eliminates the requirement for lens cleaning and disinfection and has been shown to have higher compliance rates with lens replacement schedules compared to other lens wearing modalities (Dumbleton 2009). Silicone hydrogel contact lenses provide superior oxygen transmissibility over contact lenses made with conventional materials. A new DD SiHy lens, known here as DD T2, has been developed that combines high oxygen transmissibility with a low modulus of elasticity. In this clinical trial, the performance of the investigational DD T2 lens will be compared to the commercially available DT1 (delefilcon A) lens in a parallel-group design with 3 months of exposure. The intended use of this contact lens is for vision correction. Therefore, the objective measurement of VA is planned as the primary variable for the comparison with the DT1 lens. The recommendations of ISO 11980:2012 and FDA (510(k)) Guidance Document for Daily Wear Contact Lenses in regard to variables to assess were considered.
Rationale and Background. Daily wear contact lenses are worn during waking hours, often for a full day and then removed for cleaning and disinfection prior to reinsertion the following day. Frequent replacement daily wear contact lenses are replaced according to the product package insert provided by the contact lens manufacturer. New silicone hydrogel materials continue to be developed, possessing unique material properties and superior oxygen transmissibility over contact lenses made with conventional hydrogel materials. A new lens, has been developed in an effort to maintain sustained performance by providing an inherently wettable core material with a water gradient surface. The new silicone hydrogel lens has been designed to provide favorable performance for daily wear with 1-month replacement. In this clinical study, the clinical performance of the investigational contact lens will be assessed and the contact lens will be compared to the commercially available AOHP contact lens in a crossover design, both to be worn in a daily wear modality for approximately 1 month.
Rationale and Background. Daily wear contact lenses are worn during waking hours, often for a full day and then removed for cleaning and disinfection prior to reinsertion the following day. Frequent replacement daily wear contact lenses are replaced according to the product package insert/IFU provided by the contact lens manufacturer. New silicone hydrogel materials continue to be developed, possessing unique material properties and superior oxygen transmissibility over contact lenses made with conventional hydrogel materials. A new lens, known as the TOTAL30 contact lens, has been developed in an effort to maintain sustained performance by providing an inherently wettable core material with a water gradient surface. The new silicone hydrogel lens has been designed to provide favorable performance for daily wear with 1-month replacement. In this clinical study, the clinical performance of the TOTAL30 contact lens will be assessed and the TOTAL30 contact lens will be compared to the AOHP contact lens in a crossover design, both to be worn in a daily wear modality.
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. In this clinical study, the performance of the investigational contact lens will be contact lens, worn daily as compared to Biofinity contact lens, worn daily The intended use of this contact lens is for vision correction. Therefore, the measurement of distance VA is planned as the primary effectiveness variable. compared to the commercially available Biofinity contact lens in a parallel group design to demonstrate the safety and effectiveness of the Printed By: Print Date: Document: TDOC-0056233 Status: Effective Page 24 of 59 Refer to the IB for additional information.
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.
