Rationale for Study Design Sample Clauses

Rationale for Study Design. The purpose of this study is to clinically qualify the bench studies and model predictions of visual performance of the TFNT00 IOL by demonstrating the non-inferiority in binocular visual performance to 839MP IOL and to characterize the low contrast performance and patient satisfaction with both IOLs.
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Rationale for Study Design. This study design is justified based upon an evaluation of the results of relevant preclinical and clinical testing, as described within the package inserts. The crossover design will ensure that the same subject is exposed to both the test and comparator lens materials; study will include only those subjects who are current wearers of spherical soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. Furthermore, the subjects will not be permitted to use lubrication/rewetting drops during the duration of the study as this may confound the primary effectiveness endpoint. The study will exclude any habitual DT1and Infuse contact lens wearers in the past 3 months prior to consent in order to reduce potential bias of wearers to their habitual contact lenses. The study will also exclude subjects who wish to wear their contact lenses in monovision modality during the study and multifocal lens wearers.
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Rationale for Study Design. ‌‌‌‌‌ In this study, the on-eye performance of the investigational DACP Digital lens and the commercially available DACP lens will be assessed in a prospective, double-masked, bilateral crossover design with 7 ± 2 days of exposure to each study lens. The study design as well as the exposure duration of study lenses is supported by the nonclinical and clinical data presented in the IB. The study design is well-established.
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Rationale for Study Design. Extended wear contact lenses have been marketed and tested in the United States and Europe since the 1970s. The advantage of day and night lens wear without having the need for removal for cleaning and disinfection everyday has been appealing to many contact lens wearers. For successful overnight lens wear, the lenses must not only be safe and effective but also be comfortable over the prescribed wearing period.
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Rationale for Study Design. In this clinical trial, the safety and performance of the investigational contact lens will be compared to the commercially available Biofinity contact lens in a double-masked, parallel-group design with approximately 12 months of exposure. The study is designed primarily following the recommendations for a new extended wear contact lens material from ISO 11980:2012 and the US FDA 510(k) guidance document for reporting format.
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Rationale for Study Design. 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 double-masked, parallel-group design with approximately 3 months of exposure. The study is designed following the recommendations for registration from ISO 11980:2012 and the US FDA 510(k) guidance document.
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Rationale for Study Design. This study design was selected to include symptomatic subjects as the appropriate population for this trial. Subjects will be fitted with their optimal habitual prescription and wear for approximately one week before wearing the test and control lenses. They will then be questioned again for symptoms of digital eye fatigue, with further assurance that any fatigue related symptoms are not related to a wrong prescription or old lenses that may have deposits or poor surface and thus inclusion in the study is appropriate. The age of the study population is necessary to avoid confounding with the natural lessening of accommodation with an early presbyopic population. The remaining aspects of the study design are well established. 7.2.1 Purpose and Timing of Interim Analyses and Resulting Design Adaptations
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Rationale for Study Design. The purpose of this clinical study is to evaluate effectiveness and safety of the TFNT20 when implanted to replace the natural lens following cataract removal in at least one eye based on a new Alcon Toric calculator that incorporates ocular trends in Toric IOL planning. 7.2.1 Purpose and Timing of Interim Analyses and Resulting Design Adaptations
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Related to Rationale for Study Design

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

  • Program Design The County Human Resources Department will operate a Catastrophic Leave Bank which is designed to assist any County employee who has exhausted all paid accruals due to a serious or catastrophic illness, injury, or condition of the employee or family member. The program establishes and maintains a Countywide bank wherein any employee who wishes to contribute may authorize that a portion of his/her accrued vacation, compensatory time, holiday compensatory time or floating holiday be deducted from those account(s) and credited to the Catastrophic Leave Bank. Employees may donate hours either to a specific eligible employee or to the bank. Upon approval, credits from the Catastrophic Leave Bank may be transferred to a requesting employee's sick leave account so that employee may remain in paid status for a longer period of time, thus partially ameliorating the financial impact of the illness, injury, or condition. Catastrophic illness or injury is defined as a critical medical condition, a long-term major physical impairment or disability which manifests itself during employment.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.