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NCT05300763

Clinical Performance of Senofilcon A Investigational Lens

Completed NA Results posted Last updated 22 June 2023
What this trial tests

NA trial testing senofilcon A prototype in Visual Acuity in 344 participants. Completed in 25 May 2022.

Timeline
21 March 2022
Primary endpoint
25 May 2022
25 May 2022

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment344
Start date21 March 2022
Primary completion25 May 2022
Estimated completion25 May 2022
Sites19 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 18 to 39, 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.

End of Day Comfort Primary · 2-Week Follow-up

End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.

Very Satisfied
GroupValue95% CI
Test (Senofilcon A C3)76
Control (Delefilcon A)46
Satisfied
GroupValue95% CI
Test (Senofilcon A C3)52
Control (Delefilcon A)58
Neither Satisfied nor Dissatisfied
GroupValue95% CI
Test (Senofilcon A C3)16
Control (Delefilcon A)21
Dissatisfied
GroupValue95% CI
Test (Senofilcon A C3)18
Control (Delefilcon A)35
Very Dissatisfied
GroupValue95% CI
Test (Senofilcon A C3)8
Control (Delefilcon A)10
Digital Device Use Secondary · 2-Week Follow-up

Lens performance in digital device use was assessed using an individual item "Reduction in the feeling of tired eyes from using a computer or other digital device". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.

Not Applicable
GroupValue95% CI
Test (Senofilcon A C3)2
Control (Delefilcon A)9
Excellent
GroupValue95% CI
Test (Senofilcon A C3)65
Control (Delefilcon A)47
Very Good
GroupValue95% CI
Test (Senofilcon A C3)68
Control (Delefilcon A)59
Good
GroupValue95% CI
Test (Senofilcon A C3)17
Control (Delefilcon A)26
Fair
GroupValue95% CI
Test (Senofilcon A C3)12
Control (Delefilcon A)23
Poor
GroupValue95% CI
Test (Senofilcon A C3)6
Control (Delefilcon A)6
Comfort Throughout the Day Secondary · 2-Week Follow-up

Comfort throughout the day was measured using an individual item "I could wear these contact lenses comfortably for as long as I wanted to". Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree.

Strongly Disagree
GroupValue95% CI
Test (Senofilcon A C3)12
Control (Delefilcon A)18
Disagree
GroupValue95% CI
Test (Senofilcon A C3)26
Control (Delefilcon A)48
Neither Agree Nor Disagree
GroupValue95% CI
Test (Senofilcon A C3)16
Control (Delefilcon A)17
Agree
GroupValue95% CI
Test (Senofilcon A C3)43
Control (Delefilcon A)43
Strongly Agree
GroupValue95% CI
Test (Senofilcon A C3)73
Control (Delefilcon A)44
Comfortable Vision While Night Driving Secondary · 2-Week Follow-up

Comfortable vision while night driving was assessed using an individual item "Ability to see comfortably while driving at night". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.

Not Applicable
GroupValue95% CI
Test (Senofilcon A C3)2
Control (Delefilcon A)3
Excellent
GroupValue95% CI
Test (Senofilcon A C3)91
Control (Delefilcon A)65
Very Good
GroupValue95% CI
Test (Senofilcon A C3)47
Control (Delefilcon A)57
Good
GroupValue95% CI
Test (Senofilcon A C3)25
Control (Delefilcon A)34
Fair
GroupValue95% CI
Test (Senofilcon A C3)3
Control (Delefilcon A)9
Poor
GroupValue95% CI
Test (Senofilcon A C3)2
Control (Delefilcon A)2

Sponsor's own description

This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.

Publications & conference data

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

  1. Comfort advantages demonstrated with a novel soft contact lens: A randomized clinical trial.
    Buch JR, Martin P, Xu J. · · 2024 · PMID 39553617 · DOI 10.1016/j.heliyon.2024.e39995

Verify or expand the search:

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/NCT05300763.

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