Rationale for Study Design Sample Clauses

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.
Sample 1
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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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1

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.

  • Research Design The data generated by excavations at the prehistoric site(s) will be used to examine at least three topics: (1) chronology; (2) technology; and (3) subsistence practices. Insights into changing patterns of community organization may also be granted, as may insights into changes in social organization. The data recovered will then be compared to data from other regional sites.

  • 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.

  • 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.

  • Curriculum Committee The Curriculum Committee shall consist of sixteen (16) members of the bargaining unit, three (3) students, and three (3) administrators; provided, however, that in the case of the Massachusetts College of Art and Design, the Massachusetts College of Liberal Arts and the Massachusetts Maritime Academy, the Curriculum Committee shall be composed of ten (10) members of the bargaining unit, two (2) students, and two (2) administrators.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Plan Design The flexible benefits plan is a cafeteria-style benefits program wherein the County makes a contribution toward the Flexible Benefits Plan for each eligible employee to be allocated during the employee's active employment. The County contribution is distributed by the employee among the menu of benefit options listed below, the specific details and administration of which are set forth in the plan brochures: "Core" Benefits: • Health insurance • County basic life and AD&D insurance Optional Benefits: • Dental insurance • Vision insurance • Supplemental life insurance • Supplemental accidental death and dismemberment insurance (AD&D) • Flexible spending accounts for pre-tax reimbursement of qualified medical and/or dependent day care expenses. Account credits must be used during the plan year in which they are earned for expenses incurred during the same plan year. • The plan may be modified upon written notice by the County. This plan includes for eligible employees pre-tax contributions for all monies paid toward health, dental, vision and/or voluntary AD&D plans.

  • The Design Builder shall maintain an occurrence form commercial general liability policy or policies insuring against liability arising from premises (including loss of use thereof), personal injury or death, advertising injury, liability insured under an insured contract (including the tort liability of another assumed in a business contract) occurring on or in any way related to the premises or occasioned by reason of the operations of Design-Builder. Such coverage shall be written on an ISO occurrence form (ISO Form CG 00 01 12 07 or a policy form providing equivalent coverage) in an amount of not less than $1,000,000.00 per occurrence and not less than $2,000,000.00 aggregate. Unless otherwise provided, the policy or policies of insurance providing the liability coverage shall include:

  • Withdrawal of Licensed Materials The Publisher reserves the right to withdraw from the Licensed Materials any item or part of an item for which it no longer retains the right to publish, or which it has reasonable grounds to believe infringes copyright or is defamatory, obscene, unlawful, or otherwise objectionable. The Distributor shall ensure that the Publisher will give prior written notice of the withdrawal to the Licensee and the Participating Institutions as soon as is practicable, but in no event less than thirty (30) days in advance of such withdrawal, specifying the item or items to be withdrawn.

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