Study Rationale and Purpose Sample Clauses

Study Rationale and Purpose. The purpose of this study is to evaluate biocompatibility of an investigational contact lens compared to marketed contact lenses (PureVision/Biofinity) which have been pre- cycled in OPTI-FREE RepleniSH multi-purpose disinfecting solution (RepleniSH) and/or Biotrue multi-purpose solution (Biotrue). The primary endpoint (average % area of corneal staining) was selected to fulfill the primary objective of the study. RepleniSH was chosen as a representative solution containing the Polyquarterium-1 preservative and Biotrue was chosen as a representative solution containing the polyaminopropyl biguanide (PHMB) preservative.
Sample 1
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Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. The primary endpoint was selected to fulfil the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Oasys 1-Day, MyDay, and Moist contact lenses were chosen as the control products because these lenses have the same wear modality. The new contact lens in development is intended for the optical correction of refractive myopia in persons with non-diseased eyes. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
Study Rationale and Purpose. The contact lenses for this study are intended for the optical correction of refractive myopia in persons with non-diseased eyes who are dryness symptomatic with their habitual weekly/monthly contact lenses. The primary purpose of this study is to conduct a pilot study with DAILIES TOTAL1 and Acuvue Oasys 1-Day to guide the protocol development of the subsequent larger scale head- to-head phase 4 trial. Additionally, this study is being conducted to re-fit habitual weekly/monthly symptomatic wearers into DAILIES TOTAL1 and Acuvue Oasys 1-Day The primary endpoint was selected to support the overall study objective. Procedures for measurement of this endpoint are standard in eye care professional practice. The design of this study is justified based upon preclinical and clinical testing, as described within the product´s Instructions for Use. Acuvue Oasys 1-Day contact lenses were chosen as the control product because these lenses have the same wear modality and a similar material to the DAILIES TOTAL1 lenses. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
Study Rationale and Purpose. 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 non-diseased eyes requiring subjects to wear spectacles for vision correction. The purpose of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to INFUSE contact lenses
Sample 1
Study Rationale and Purpose. The new contact lens in development is intended for the optical correction of refractive ametropia in persons with non-diseased eyes. The purpose of this study is to obtain on-eye performance data to inform contact lens product development. The primary endpoint was selected to address the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Biofinity contact lenses were chosen as the control product because these lenses have the same wear modality and replacement schedule.
Sample 1
Study Rationale and Purpose. The new contact lens in development is intended for the optical correction of refractive ametropia in persons with non-diseased eyes. The purpose of this study is to evaluate performance of two commercially available daily wear frequent replacement silicone hydrogel soft contact lenses as compared to investigational test product (LID018869) to obtain on-eye performance data The primary endpoint was selected to address the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments.
Sample 1
Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population. The primary endpoint was selected to fulfill the primary objective of the study. Procedures for measurement of these endpoints were selected based on common practice for these assessments. The design of this study is justified based upon preclinical and clinical testing, as described within the Investigator’s Brochure. Clariti 1 Day contact lenses were chosen as the control product because these lenses have the same wear modality. The new contact lens in development is intended for the optical correction of refractive myopia in persons with non-diseased eyes. There are no immediate plans to submit the results of this study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1
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Study Rationale and Purpose. The purpose of this study is to obtain on-eye performance data to aid contact lens product development. 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. The design of this study is justified based upon FDA approval and information, as described within the Package Inserts. BIOFINITY contact lenses were chosen as the control product because these lenses have the same wear modality, material, and parameters to the test product BIOFINITY ENERGYS, and are the spherical design as compared to the aspherical design, respectively. There are no immediate plans to submit the results of this early clinical development study for publication; however, the results may be offered for publication if they are of scientific interest, or if the results relate to a product that is subsequently approved or cleared for marketing.
Sample 1

Related to Study Rationale and Purpose

  • Scope and Purpose 1.01 This document is intended to set out general guidelines and principles regarding child welfare sector integrations during the term of this agreement which are mandated by the Ministry and for which local Human Resources Adjustment Plans (HRAP) are required to be negotiated. Subject to the following terms, these principles will serve as the framework for the treatment of bargaining unit employees and will apply to subsequent negotiations with unions, as may be required, as part of an integration arising within the context of the Ontario Labour Relations Act (OLRA) or PSLRTA, whichever is applicable.

  • Introduction and Purpose The Kentucky Community and Technical College System (KCTCS) and the Kentucky Department of Education (KDE) mutually support the attainment of dual credit coursework for high school students. This Memorandum of Understanding (MOU) underscores the dedication of both agencies to improving the educational attainment of Kentucky citizens and reinforces the collaboration necessary to achieve this level of success. Improving the educational attainment of Kentucky citizens is key to ensuring the State’s long-term success. The State commits significant resources across the educational spectrum to develop and implement strategies to address this critical issue. Providing secondary students dual credit opportunities is a proven educational strategy with the capacity to complement and maximize the chances of success of our educational initiatives. Effective dual credit systems have impacts both at the secondary and postsecondary levels and provide the opportunity for collaboration. Participants are expected to know and follow current and future versions of Dual Credit Policies established by the Kentucky Council on Postsecondary Education found at: xxxx://xxx.xx.xxx/policies/dualcredit.html. Should policies change during the academic year, KCTCS may request support in meeting those changes outside the scope of this document.

  • Background and Purpose Executive was employed by the Company. Executive's employment is ending effective __________ under the conditions described in Section 3.1 of the Executive Change of Control Agreement ("Agreement") by and between Executive and the Company dated _____________, 2012. The purpose of this Release is to settle, and the parties hereby settle, fully and finally, any and all claims the Releasing Parties may have against the Released Parties, whether asserted or not, known or unknown, including, but not limited to, claims arising out of or related to Executive's employment, any claim for reemployment, or any other claims whether asserted or not, known or unknown, past or future, that relate to Executive's employment, reemployment, or application for reemployment.

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