Outline of Study Sample Clauses

Outline of Study. This will be a multi-site, prospective, randomized, parallel crossover, double-masked study comparing 4 contact lenses. The expected duration of subject participation in the study is approximately 20 days, with 3 scheduled visits. The study is expected to be completed in approximately 7 weeks.
Sample 1See All (6)
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Outline of Study. Prior to informed consent and scheduling the Screening visit, subjects will be given the Pre-screening Questionnaire (Symptomatology Questionnaire, Digital Device Use assessment and HMPS Identification Tool). These may be administered via a combination of phone, email, or in person; (Note: the HMPS Identification Tool is visual). Once the subject completes the questionnaire and the replies indicate the subject to be eligible to proceed then informed consent must be obtained from the subject before any procedure specified by this protocol is initiated, including Screening procedures at Visit 1. The original signed informed consent must be maintained with the subject’s file whether they pass or fail Screening. A copy of the signed informed consent form will be provided to the subject. Data from the Pre-screening Questionnaire will not be entered into to the electronic case report forms (eCRFs) but will stay in the subject file as source documents for monitoring of both randomized subjects and screen failures. Those who pass pre-screening and sign informed consent may attend the Screening visit (Section 10.2.1). Subjects who are scheduled to attend the Screening visit must have a new bottle of the HMPS identified during pre-screening ready for possible dispensing at the end of the Screening visit after randomization. This can be accomplished in two ways for the study: 1) The subject purchases a new bottle of the HMPS and brings it to the Screening visit. In this case the subject will be reimbursed for their purchase. The unmasked coordinator must confirm the solution purchased was the HMPS identified during pre-screening and that it is not expired. If HMPS is randomized to be used for Period 2, the site will maintain the purchased HMPS at the site for the subject until Period 2; 2) The site purchases the subject’s HMPS and dispenses to the subject according to the randomization schedule. Adverse events (AEs)/serious adverse events (SAEs) and device deficiencies will be assessed and reported at all scheduled and unscheduled study visits for each subject from the time of informed consent. Figure 10–1 Diagram of Study Design‌‌ Screening/ Baseline (Visit 1) Pre-Screening Questionnaire Presbyopic contact lens wearers
Sample 1
Outline of Study. This will be a single-site, prospective, randomized, double-masked, contralateral crossover study comparing 3 contact lenses pre-cycled in two different MPDS. The expected duration of subject participation in the study is approximately up to 1 week, with 2 study visit days. The study is expected to be completed in approximately 1.5 months. Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and MPDS combinations: Sequence 1: LID018869+RepleniSH (OD)/Biofinity+RepleniSH (OS)//PV+Biotrue (OD)/LID018869+Biotrue (OS) Sequence 2: Biofinity+RepleniSH (OD)/LID018869+RepleniSH (OS)//LID018869+Biotrue (OD)/PV+Biotrue (OS) Sequence 3: LID018869+Biotrue (OD)/PV+Biotrue (OS)//Biofinity+RepleniSH (OD)/LID018869+RepleniSH (OS) Sequence 4: PV+Biotrue (OD)/LID018869+Biotrue (OS)//LID018869+RepleniSH (OD)/Biofinity+RepleniSH (OS) 4.1 Identity of Study Treatments
Sample 1
Outline of Study. This will be a multisite, prospective, randomized, crossover, double-masked, stratified (by symptomatology) study comparing 2 contact lenses. The expected duration of subject participation in the study is up to 24 days, with 3 scheduled visits. The study is expected to be completed in approximately 11 weeks. Subjects will be randomized in a 1:1 manner to receive treatment (lens) in a crossover sequence: Test product then Control product, or Control product the Test product, respectively. Sequence EDC/randomization integration system Lens Name Sequence 1 PRECISION1/INFUSE Sequence 2 INFUSE/PRECISION1 Lens PRECISION1 INFUSE Material Verofilcon A Kalifilcon A Water Content 51% 55% Base Curve (mm) 8.3 8.6 Diameter (mm) 14.2 14.2 Rx Power Range -1.00 to 6.00 D in 0.25 D steps, as available -1.00 to 6.00 D in 0.25 D steps, as available Packaging, Labeling, and Supply • Blister foil pack • Foil label includes at a minimum: - Identifier - base curve - diameter - packing solution - power - lot number - expiration date - content statement - investigational device statement - sponsor information - country of origin. • Provided in ~ 12 lenses per power per carton, identified with the following at a minimum: - a color coded label stating the protocol number - power - an investigational use only statement - tracking number. • Lenses should be stored at room temperature. • study lenses will be provided by the sponsor before the start of the study • Blister foil pack • Foil label includes at a minimum: - Identifier - base curve - diameter - packing solution - power - lot number - expiration date - content statement - investigational device statement - sponsor information - country of origin. • Provided in ~ 12 lenses per power per carton, identified with the following at a minimum: - a color coded label stating the protocol number - power - an investigational use only statement - tracking number • Lenses should be stored at room temperature. • study lenses will be provided by the sponsor before the start of the study Usage • Wear: o Daily Wear o Bilateral • Replacement period: Daily Disposable • Exposure: o ~16 days total duration (Test and Control) • Lens Care: N/A • Both study contact lenses will be used according to their registered/approved indications for use and within the approved wearing schedule and duration.
Sample 1

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