An interventional study of etafilcon A in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 9 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-24.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.
Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
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Exclusion Criteria:
Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits.
Device: etafilcon A
Investigational Contact Lens
Overall Vision
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.
Time frame: 12-16 Day Follow-up
A total of 72 subjects were enrolled into this study. Of the enrolled subjects 63 were dispensed at least one study lens and 9 did not meet the eligibility criteria. All 63 dispensed subjects completed the study.
| Milestone | Etafilcon A With PVP |
|---|---|
| Started | 63 |
| Completed | 63 |
| Not completed | 0 |
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.
| Units on a Scale | Etafilcon A With PVP |
|---|---|
| Overall Vision | 47.33 ± 18.646 |
Collected over Throughout the entire duration of the study. Approximately 2-weeks per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etafilcon A With PVP | 0/63 (0%) | 0/63 (0%) | 0/63 (0%) |
| Age, Continuous(Years) | Etafilcon A With PVP |
|---|---|
| Mean | 56.5 ± 6.65 |
| Sex: Female, Male(Participants) | Etafilcon A With PVP |
|---|---|
| Female | 48 |
| Male | 15 |
| Race/Ethnicity, Customized(Participants) | Etafilcon A With PVP |
|---|---|
| Black or African American | 2 |
| White | 61 |
| Region of Enrollment(Participants) | Etafilcon A With PVP |
|---|---|
| United States | 63 |
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Vision Care, Inc.