Control
DeviceACUVUE OASYS
NCT Number: NCT03228212
This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.
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Notify Me18 year–49 year
All sexes
Interventional
Not applicable
Dr. James Weber & Associates, PA, Jacksonville, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ACUVUE OASYS
senofilcon A with new UV blocker
Time frame: 2-Week Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average comfort score from the 3 study periods was reported.
Time frame: 2-Week Follow-up
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.
Time frame: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.
Time frame: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.
Time frame: 2-Week Follow-up
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average vision score from the 3 study periods was reported.
Time frame: 2-Week Follow-up
Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average handling score from the 3 study periods was reported.
Johnson & Johnson Vision Care, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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