PROCEDURES AND ASSESSMENTS. Efficacy The primary efficacy endpoint will be the number of BA058-treated patients showing new vertebral fractures at End-of-Treatment when compared to Placebo. New incident vertebral fractures will be evaluated according to the method of Genant (1). Efficacy assessments will therefore include documentation of the incidence of clinical and radiographic fractures of the lumbar and thoracic spine. Patients will undergo baseline and End-of-Treatment antero-posterior and lateral radiographs of the lumbar and thoracic spine. All radiographs will be viewed and assessed by a blinded, independent assessor (radiologist) on the basis of existing baseline and study-acquired vertebral deformity, and fracture will be assessed according to a set of pre-determined criteria. A second blinded radiologist will review the assessment of the first reviewer for all patient radiographs in which an incident fracture has been identified. In the case of any disagreement, a third consensus assessment will be made to adjudicate the incident fracture. A standardized graded scale of severity of the vertebral deformity will be evaluated according to the method of Genant (1). Secondary efficacy parameters will also include reduction in the incidence of non-vertebral fractures (wrist, hip, rib, etc.) and reduction in moderate and severe vertebral fractures. Clinical fracture occurring de novo at these anatomical sites during the study will also be assessed and analyzed. Other secondary efficacy endpoints will include changes in BMD of spine, hip, and femoral neck, and wrist from baseline to end-of-treatment as assessed by DXA. Patients will undergo BMD assessments at Screening (spine and hip; all patients), at Day 1 (wrist; in a subset of patients), and at Months 6, 12 and 18 (End-of-Treatment) of study participation. Any patient who shows a continuing significant deterioration (>7%) of BMD at spine or hip will have the assessment repeated and, if confirmed, will be discontinued from the study. Patients sustaining an incident vertebral or non-vertebral fragility fracture will be informed of the finding and offered the opportunity to remain in or discontinue from the study. Additional secondary endpoints will include change in standing height and changes in serum bone markers across treatment, such as PINP, osteocalcin, and bone-specific alkaline phosphatase. Serum C-telopeptides (CTX), a marker of bone resorption and collagen breakdown, will be measured and reported. Bone markers will be...
PROCEDURES AND ASSESSMENTS. Subjects will wear each study product in a daily wear, daily disposable modality for 7 ± 2 days per study product, with up to 4 scheduled visits. Per Inclusion Criteria #5, subjects are willing to wear the study lenses each day as possible (including the day of the follow-up visits) and at least 8 hours per day unless contact lens wear is contraindicated. • Visit 1 – Baseline/ Fitting • Visit 2 – Dispense Study Product 1 [0 - 7 days from Visit 1] • Visit 3 – 1-Week Follow-up Study Product 1 [7 ± 2 days from Visit 2] / Dispense Study Product 2 • Visit 4 – 1-Week Follow-up Study Product 2 [7 ± 2 days from Visit 3] / Exit The following assessments will be performed for each study product: • Distance VA with study lenses (logMAR, , OU) . Subjects will also be asked to complete the following series of questionnaires related to their lens wearing experiences with each study product: • Subjective ratings as related to vision,
PROCEDURES AND ASSESSMENTS. Subjects will be expected to attend 6 office visits, as shown below. Visit # Visit Type Visit Day
PROCEDURES AND ASSESSMENTS. Subjects will be expected to attend 6 office visits, as shown below. Visit # Visit Type Visit Day Visit Window Visit 1 Screening/Baseline/Dispense Day 1 N/A Visit 2 Week 1 Follow-up Visit Day 8 Days 6-10 Visit 3 Week 2 Follow-up Visit Day 15 Days 12–18 Visit 4 Month 1 Follow-up Visit Day 30 Days 27–35 The Investigator or delegate must provide a copy of the signed document to the subject and place the original signed document in the subject’s chart, or provide documentation as required by local regulations.
PROCEDURES AND ASSESSMENTS. Subjects will be expected to attend 3 office visits, as shown below. Visit # Visit Type Visit Window Visit 1 Screen/Baseline/Dispense Lens 1 N/A Visit 2 Week 1 Follow-up Lens 1 8 days after Visit 1 Visit 3 Week 1 Follow-up Lens 2/Exit 8 days after Visit 2 Unscheduled Visits and Early Termination Visits are allowed, if necessary. Study lenses will be provided to the subjects to take home for daily wear during the course of the trial. Study randomization will occur at Visit 1 with assigned lenses provided to take home at Visit 1 and Visit 2. Lubrication/rewetting drops will not be permitted during this study.
PROCEDURES AND ASSESSMENTS. Below examinations and observations are carried out at Visit 0/0A, Visit 00/00A, Visit 1/1A, Visit 2/2A and Visit 3/3A. The same instruments and methods should be used for all measurements at all visits. Examinations and observations are outlined in tabular format in Section 6 of this protocol. Both the examination and the observation may be per Visited on the same day if the day is within the window for the examination and observation of the eye concerned (first or second operated eye). Also examination and observation can be performed separately over days if these are performed within the set window.
PROCEDURES AND ASSESSMENTS. Complete details of the study assessments are provided in Section Error! Reference source not found.Error! Reference source not found. and Appendix Error! Reference source not found.Error! Reference source not found.. Appendix Error! Reference source not found. Error! Reference source not found. provides a detailed list of activities for each study visit.
PROCEDURES AND ASSESSMENTS. Subjects will be expected to attend 1-2 office visits. Visit 1/Screening visit procedures may be performed the same day as Visit 2 procedures. Visit 2 should occur 0-14 days from Visit 1. Study randomization for the contact lens group should occur at Visit 2 if it is performed on a separate date as the Visit 1/Screening visit. All study contact lenses will be prescribed according to the subject’s prescription and fitted using the Xxxxx XX fitting guide. A subject’s participation will be terminated if the subject does not achieve a successful fit with the Alcon Precision Profile Design study lenses according to the MF fitting guidelines or at the Investigator’s discretion. PAL wearers will wear their habitual spectacles. Used study contact lenses will be removed at the subject’s exit and destroyed by the site.
PROCEDURES AND ASSESSMENTS. Subjects will be expected to attend 4 office visits, as shown below. N/A Day 95 Month 3 Follow-up / Exit Visit Visit 4 Day 30 Month 1 Follow-up Visit Visit 3 Day 7 Week 1 Follow-up Visit Visit 2 Day 1 Screening / Baseline / Dispense Visit 1 Visit Window Visit Day Visit Type Visit #
PROCEDURES AND ASSESSMENTS. Subjects will be expected to attend 3 office visits, as shown below. Visit # Visit Type Visit Window Visit 1 Screening/Baseline/Dispense Lens 1 N/A Visit 2 Week 1 Follow-up Lens 1/Dispense Lens 2 8 (-0/+3) days after Visit 1 Visit 3 Week 1 Follow-up Lens 2/Exit 8 (-0/+3) days after Visit 2 Unscheduled Visits and Early Exit Visits are allowed, if necessary. Study lenses will be provided to the subjects to take home for daily wear during the course of the trial. Study randomization will occur at Visit 1 with assigned lenses provided to take home at Visit 1 and Visit 2. Study contact lens fitting will occur at Visit 1 for both study lenses. If a subject cannot be successfully fit (either study lens) according to the study lens fitting guides as determined by the investigator, they will be required to exit from the study. Lubrication/rewetting drops will not be permitted during this study. Study tests, procedures, and questionnaires will be conducted as outlined in the MOP.
