Adults 18 to 59, 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.
Change From Baseline Comfort ScorePrimary· Up to 2-Week Follow-up
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 change from baseline was calculated as 2-week follow-up minus bas
Group
Value
95% CI
Arm 1
28.99
± 26.766
Arm 2 (Subjects' Own Contact Lens)
-0.29
± 10.245
Change From Baseline CLDEQ-8 ScoreSecondary· Up to 2-Week Follow-up
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher
Group
Value
95% CI
Arm 1
-10.83
± 6.631
Arm 2 (Subjects' Own Contact Lens)
-1.23
± 3.638
Comfort ScoreSecondary· 2-Week Follow-up
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 was reported for each group within Arm 2 on
Group
Value
95% CI
Arm 2 (Senofilcon A)
55.88
± 25.721
Arm 2 (Subjects' Own Contact Lens)
29.69
± 13.849
CLDEQ-8 ScoreSecondary· 2-Week Follow-up
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher
Group
Value
95% CI
Arm 2 (Senofilcon A)
12.46
± 6.078
Arm 2 (Subjects' Own Contact Lens)
21.18
± 3.698
Adverse events — posted to ClinicalTrials.gov
Time frame: Throughout the entire duration of the study. For subject in Arm 1 their study duration was approximately 2-weeks while subjects in Arm 2 study duration was approximately 1-month..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05021081 — Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
· NA
· completed
NCT04968925 — Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
· NA
· completed
Other recruiting trials for Visual Acuity
Currently open trials in the same condition.
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NCT04632901 — A New Parameter for the Assessment of Distance Visual Capacity: the Critical Visual Acuity (CVA)
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Other Johnson & Johnson Vision Care, Inc. trials
Trials by the same sponsor.
NCT07443215 — Evaluation of Effect of Scatter on Visual Performance
· NA
· recruiting
NCT07174596 — Evaluation of Approved Contact Lenses
· NA
· completed
NCT07076160 — Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses
· NA
· completed
NCT06967129 — Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process
· NA
· completed
NCT06864858 — Clinical Evaluation of Two Cosmetic Contact Lenses
· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc.
Last refreshed: 10 October 2022
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/NCT04849780.