N/A
Completed N=146
ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
Vision Satisfaction in Bright Light
Source: ClinicalTrials.gov NCT04116736 ↗
Enrolled (actual)
146
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Vision Satisfaction in Bright Lighting - 2-Week Questionnaire — 33; 21; 33; 24 Responses
Summary
This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vision Satisfaction in Bright Lighting - 2-Week Questionnaire |
33; 21; 33; 24; 10; 2 | — |
| PRIMARY Vision Satisfaction in Bright Lighting - 4-Month Questionnaire |
24; 20; 38; 25; 7; 2 | — |
| PRIMARY Vision Satisfaction in Bright Lighting - 12-Month Questionnaire |
23; 22; 29; 21; 4; 2 | — |
| SECONDARY Overall Quality of Vision - 2-Week Questionnaire |
37; 27; 36; 20; 3; 0 | — |
| SECONDARY Overall Quality of Vision - 4-Month Questionnaire |
31; 22; 35; 23; 5; 2 | — |
| SECONDARY Overall Quality of Vision - 12-Month Questionnaire |
25; 18; 30; 25; 1; 2 | — |
| SECONDARY Overall Comfort - 2-Week Questionnaire |
19; 9; 37; 28; 17; 9 | — |
| SECONDARY Overall Comfort - 4-Month Questionnaire |
27; 16; 25; 19; 12; 9 | — |
| SECONDARY Overall Comfort - 12-Month Questionnaire |
20; 10; 28; 23; 8; 9 | — |
| SECONDARY Pulfrich Effect |
4; 1; 4; 0; 0; 1 | — |
| SECONDARY Serious or Significant Adverse Events |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses.
- A minimum age of 18 years, with no maximum age.
- The registrant must read and sign the Informed Consent form.
- The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Current participant in another research study.
- Employee or relative of site, or family member of Recruiting Practitioner or Johnson & Johnson.
- Non-spherical contact lens wearers, i.e. toric or multifocal lenses.
Data sourced from ClinicalTrials.gov (NCT04116736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.