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NCT03228212 · ClinicalTrials.gov registry record · NA
Evaluation of Approved and Investigational Contact Lenses
A NA study, sponsored by Johnson & Johnson Vision Care.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
NCT03228212: Completed NA study, sponsored by Johnson & Johnson Vision Care.
NCT03228212 is a NA study that has completed, run by Johnson & Johnson Vision Care. The registered enrollment target is 133 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03228212, a NA study, has completed, sponsored by Johnson & Johnson Vision Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
Study Summary
This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.
Primary Outcome
Overall 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/po
Interventions
- DEVICE CONTROL
- DEVICE TEST
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2017-09-18 |
| Phase | NA |
What the finished NCT03228212 record still lists
NCT03228212 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which CONTROL is the first listed.
NCT03228212 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03228212 about?
NCT03228212 is a clinical study titled "Evaluation of Approved and Investigational Contact Lenses". This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the...
What is the current status of trial NCT03228212?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2017-07-14. Estimated completion is 2017-09-18.
What interventions are being tested in trial NCT03228212?
The interventions under investigation include: CONTROL (DEVICE), TEST (DEVICE).
Who is sponsoring clinical trial NCT03228212?
This trial is sponsored by Johnson & Johnson Vision Care, which has 142 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03228212's enrollment target sits among peer trials
133 729th of 2000 higher than 1,272 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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