senofilcon A TEST Lens
Devicesenofilcon A with new UV blocker investigational process
NCT Number: NCT03475875
This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
VRC-West, Foster City, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
senofilcon A with new UV blocker investigational process
senofilcon A with new UV blocker standard process
Time frame: 2- Week Follow-up Evaluation
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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
Time frame: 2- Week Follow-up Evaluation
Overall 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens 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.