Visits and Examinations. CI shall enable IBRD and GEF representatives to visit facilities and sites included in the RIT Subprojects, Subprojects and activities and to examine the goods financed out of the Fund and any installations, sites, works, records and documents relevant to the operations financed under the Fund.
Visits and Examinations. 16
1.1 Visit 1 (Day 1) – Baseline/Fitting/Dispense 16
Visits and Examinations.
9.1.1. Visit 1 (Screening)
1. Subjects will report to the clinic for screening to determine if they are eligible to be in the study.
2. Prior to beginning of any study related activities, subjects will be informed about the purpose and nature of the study, the expected post-procedure events, and the potential risks involved with the surgical procedure and treatment product.
3. Subjects will be given an ICF, HIPAA form, and photography release form to read.
4. Once subjects have completed reading, they will be interviewed to ensure their understanding of the aforementioned forms and be given the opportunity to ask any study related questions.
5. Subjects who agree to sign the aforementioned forms will be asked to complete a demographic information, medical history form, and concomitant medication form. Subjects declining to sign any of the forms will be dismissed from the study.
6. Subjects will be screened and qualified on the basis of the subject inclusion and exclusion criteria. Subjects failing to meet criteria will be dismissed from the study.
9.1.2. Visit 2 (Baseline/Day 0 – Surgical procedure)
1. Investigator or clinic staff will ask the subjects if they have experienced any changes in their health since the previous visit.
2. Before the surgical procedure, the assessments below will be completed:
a. Clinical grading by Investigator as described in section 10.1
b. Tolerability assessment by the subjects as described in section.
3. The surgical area will be assessed and prepped for the procedures, followed by procedure execution by Investigator.
4. After the surgical procedure, the assessments below will be completed:
a. Standardized photography as described in section 10.3
b. Clinical grading by Investigator as described in section 10.1
c. Tolerability assessment by the subjects as described in section 10.2
5. Investigator or clinic staff will apply the treatment product to the surgical site followed by standard bandage.
6. Subjects will be given the treatment product with instruction of application, a diary to record usage of the treatment product, and when to contact the Investigator in case of emerging AEs.
7. Subjects will be scheduled for a follow-up visit at Day 7 or 14 (±2 days) and dismissed from the Clinic.
9.1.3. Visit 3 (Day 7 or Day 14 ±2 days)
1. Clinic staff or Investigator will record any AEs that are observed or reported.
2. The surgical site will be assessed in the following:
a. Clinical grading by Investigator as described in s...
Visits and Examinations. 5.1.1 Visit 1 (Day 1) – Screen / Baseline / Lens 1: Dispense
2. Obtain demographic information and medical history, including information on all medications used within the past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as prescription medications.
3. Perform logMAR VA with habitual correction. • OD, OS, distance only, contact lenses Record habitual lens information (brand, power) and lens care information (brand).
Visits and Examinations. 5.1.1 Visit 1 – Screening/Baseline/Order Spectacles
Visits and Examinations. Study lenses must be pre-cycled with RepleniSH or Biotrue prior to dispensing.
Visits and Examinations. 5.1.1 Visit 1 (Day 1) – Baseline/Dispense Lens 1
Visits and Examinations. Visit 1 (Day 0) – Screening/Baseline/Dispense Lens 1
Visits and Examinations.
9.1.1. Visit 1 (Screening/D0/Baseline)
1. Subjects will report to the testing clinic at D0 for baseline screening.
2. Subjects will be screened and qualified on the basis of the subject inclusion and exclusion criteria. Subjects failing to meet criteria will be dismissed from the study.
3. Prior to beginning of any study related activities, subjects will be informed about the purpose and nature of the study, the expected post-treatment events, and the potential risks involved with the treatments.
4. Subjects will be given an informed consent form, HIPAA form, and photography release form to read.
5. Once subjects have completed reading, they will be interviewed to ensure their understanding of the aforementioned forms and be given the opportunity to ask any study related questions.
6. Subjects who agree to sign the aforementioned forms will be asked to complete a demographic information, medical history form, and concomitant medication form. Subjects declining to sign any of the forms will be dismissed from the study.
7. Female subjects will need to perform UPT to confirm childbearing potential.
8. Subjects will be assigned to a treatment group and side of punch biopsy at the NLF based on the predetermined computer-generated randomization.
9. Subjects will participate in the following procedures completed by the Investigator or a trained clinic staff:
a. 3D clinical photography by Cherry Imaging of full face as described in section 10.2
b. A 3-mm punch biopsy at the assigned side of the NLF as described in section 10.3
10. Investigator will then instruct the subjects on the assigned treatment administration procedure and perform the treatment into both left and right NLFs.
11. Investigator or clinic staff will record the details of the administration, amount of each treatment used for each NLF and any subsequent adverse events (AEs) in the CRF.
12. Subjects will be instructed on any standard care post-biopsy and post-treatment, and when to contact the Investigator in case of emerging AEs.
13. Subjects will be scheduled to return to the clinic in 5 days (±1 day) and dismissed from the clinic. Note: Whenever possible, the same Investigator/staff that perform the baseline assessments and treatments should perform these assessments for each individual subject for the entire duration of the study. In the event of a change in the assigned Investigator/staff for a given subject, the reason for change must be documented.
9.1.2. Visit 2 (D5 ±1 day)
1. Clinic st...
Visits and Examinations.
8.1.1. Screening/Baseline/Day 0 Visit (Visit 1)
1. Subjects will report to the testing clinical at D0 for baseline screening.
2. Prior to beginning of any study related activities, subjects will be informed about the purpose and nature of the study, the expected post-treatment events, and the potential risks involved with the treatments.
