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NCT04968925

Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses

Completed NA Results posted Last updated 22 December 2022
What this trial tests

NA trial testing ACUVUE Oasys 1-Day in Visual Acuity in 302 participants. Completed in 25 October 2021.

Timeline
12 July 2021
Primary endpoint
25 October 2021
25 October 2021

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment302
Start date12 July 2021
Primary completion25 October 2021
Estimated completion25 October 2021
Sites10 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 18 to 40, any sex, with Visual Acuity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Comfort (Phase I) Primary · 1-Week Follow-up

Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)45
Verofilcon A32
Very Good
GroupValue95% CI
Senofilcon A (C3)20
Verofilcon A23
Good
GroupValue95% CI
Senofilcon A (C3)5
Verofilcon A9
Fair
GroupValue95% CI
Senofilcon A (C3)2
Verofilcon A7
Poor
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A1
End of Day Comfort (Phase I) Primary · 1-Week Follow-up

End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)29
Verofilcon A25
Very Good
GroupValue95% CI
Senofilcon A (C3)28
Verofilcon A17
Good
GroupValue95% CI
Senofilcon A (C3)9
Verofilcon A16
Fair
GroupValue95% CI
Senofilcon A (C3)4
Verofilcon A10
Poor
GroupValue95% CI
Senofilcon A (C3)2
Verofilcon A4
End of Day Dryness (Phase I) Primary · 1-Week Follow-up

End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)26
Verofilcon A22
Very Good
GroupValue95% CI
Senofilcon A (C3)28
Verofilcon A20
Good
GroupValue95% CI
Senofilcon A (C3)9
Verofilcon A12
Fair
GroupValue95% CI
Senofilcon A (C3)6
Verofilcon A12
Poor
GroupValue95% CI
Senofilcon A (C3)3
Verofilcon A6
End of Day Comfort (Phase II) Primary · 1-Week Follow-up

End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)89
Verofilcon A65
Very Good
GroupValue95% CI
Senofilcon A (C3)63
Verofilcon A59
Good
GroupValue95% CI
Senofilcon A (C3)24
Verofilcon A39
Fair
GroupValue95% CI
Senofilcon A (C3)26
Verofilcon A34
Poor
GroupValue95% CI
Senofilcon A (C3)8
Verofilcon A13
End of Day Dryness (Phase II) Primary · 1-Week Follow-up

End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)83
Verofilcon A53
Very Good
GroupValue95% CI
Senofilcon A (C3)55
Verofilcon A64
Good
GroupValue95% CI
Senofilcon A (C3)27
Verofilcon A32
Fair
GroupValue95% CI
Senofilcon A (C3)32
Verofilcon A41
Poor
GroupValue95% CI
Senofilcon A (C3)13
Verofilcon A20
Overall Comfort (Phase II) Primary · 1-Week Follow-up

Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)127
Verofilcon A104
Very Good
GroupValue95% CI
Senofilcon A (C3)44
Verofilcon A59
Good
GroupValue95% CI
Senofilcon A (C3)28
Verofilcon A30
Fair
GroupValue95% CI
Senofilcon A (C3)11
Verofilcon A13
Poor
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A3
Not Applicable
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A1
Comfort Throughout the Day (Phase II) Secondary · 1-Week Follow-up

Comfort Throughout the Day was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Excellent
GroupValue95% CI
Senofilcon A (C3)96
Verofilcon A76
Very Good
GroupValue95% CI
Senofilcon A (C3)55
Verofilcon A56
Good
GroupValue95% CI
Senofilcon A (C3)29
Verofilcon A45
Fair
GroupValue95% CI
Senofilcon A (C3)26
Verofilcon A25
Poor
GroupValue95% CI
Senofilcon A (C3)4
Verofilcon A8
Comfort While Using Digital Devices (Phase II) Secondary · 1-Week Follow-up

Comfort while Using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets)" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Not Applicable
GroupValue95% CI
Senofilcon A (C3)1
Verofilcon A2
Excellent
GroupValue95% CI
Senofilcon A (C3)111
Verofilcon A90
Very Good
GroupValue95% CI
Senofilcon A (C3)46
Verofilcon A61
Good
GroupValue95% CI
Senofilcon A (C3)33
Verofilcon A31
Fair
GroupValue95% CI
Senofilcon A (C3)17
Verofilcon A22
Poor
GroupValue95% CI
Senofilcon A (C3)2
Verofilcon A4
Dryness While Using Digital Devices (Phase II) Secondary · 1-Week Follow-up

Dryness while using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Not Applicable
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A2
Excellent
GroupValue95% CI
Senofilcon A (C3)102
Verofilcon A79
Very Good
GroupValue95% CI
Senofilcon A (C3)55
Verofilcon A63
Good
GroupValue95% CI
Senofilcon A (C3)25
Verofilcon A31
Fair
GroupValue95% CI
Senofilcon A (C3)22
Verofilcon A31
Poor
GroupValue95% CI
Senofilcon A (C3)6
Verofilcon A4
Lens Awareness Upon Insertion (Phase II) Secondary · 1-Minute Post lens fitting

Lens Awareness Upon Insertion was assessed using the individual questionnaire item "I lost awareness of these lenses shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.

Strongly Disagree
GroupValue95% CI
Senofilcon A (C3)16
Verofilcon A16
Disagree
GroupValue95% CI
Senofilcon A (C3)6
Verofilcon A13
Neither Agree nor Disagree
GroupValue95% CI
Senofilcon A (C3)7
Verofilcon A8
Agree
GroupValue95% CI
Senofilcon A (C3)65
Verofilcon A71
Strongly Agree
GroupValue95% CI
Senofilcon A (C3)126
Verofilcon A113
Comfort Upon Insertion (Phase II) Secondary · 1-Minute Post lens fitting

Comfort Upon Insertion was assessed using the individual questionnaire item "These lenses were comfortable shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.

Strongly Disagree
GroupValue95% CI
Senofilcon A (C3)2
Verofilcon A6
Disagree
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A3
Neither Agree nor Disagree
GroupValue95% CI
Senofilcon A (C3)4
Verofilcon A9
Agree
GroupValue95% CI
Senofilcon A (C3)61
Verofilcon A64
Strongly Agree
GroupValue95% CI
Senofilcon A (C3)153
Verofilcon A139
Overall Ease of Handling (Phase II) Secondary · 1-Week Follow-up

Overall Ease of Handling was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.

Not Applicable
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A2
Excellent
GroupValue95% CI
Senofilcon A (C3)140
Verofilcon A112
Very Good
GroupValue95% CI
Senofilcon A (C3)36
Verofilcon A40
Good
GroupValue95% CI
Senofilcon A (C3)23
Verofilcon A32
Fair
GroupValue95% CI
Senofilcon A (C3)11
Verofilcon A16
Poor
GroupValue95% CI
Senofilcon A (C3)0
Verofilcon A8

Sponsor's own description

This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Silicone hydrogel versus hydrogel soft contact lenses for differences in patient-reported eye comfort and safety.
    Haworth K, Travis D, Leslie L, Fuller D, et al · · 2023 · cited 10× · PMID 37724689 · DOI 10.1002/14651858.cd014791.pub2

Verify or expand the search:

Other trials of ACUVUE Oasys 1-Day

Trials testing the same drug.

Other recruiting trials for Visual Acuity

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04968925.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing