Examples of Device in a sentence
Investigational Product Type Device Study Type Interventional Investigational Products Test Product: soft contact lenses Control Product: CooperVision® BIOFINITY® (comfilcon A) soft contact lenses Purpose and Rationale The purpose of this clinical study is to evaluate the on-eye performance of the investigational lens compared to the commercially available Biofinity lens for up to 6 nights/7 days of continuous wear.
The Investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately.
Should the EDC system become non-operational, the site must complete the appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form.
Safety • AEs • Biomicroscopy findings • Device deficiencies Assessments Effectiveness • VA (Snellen distance) with study lenses • Safety • AEs • Biomicroscopy • Device deficiencies Study Design This will be a prospective, randomized, controlled, double-masked, contralateral clinical trial.
The safety endpoints are: • AEs • Biomicroscopy findings • Device deficiencies There are no safety hypotheses planned in this study.