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NCT03701516 · ClinicalTrials.gov registry record · NA

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

A NA study, sponsored by Johnson & Johnson Vision Care.

Completed
Registry status
NA
Development phase
268
Enrollment target

NCT03701516: Completed NA study, sponsored by Johnson & Johnson Vision Care.

NCT03701516 is a NA study that has completed, run by Johnson & Johnson Vision Care. The registered enrollment target is 268 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03701516, a NA study, has completed, sponsored by Johnson & Johnson Vision Care.

COMPLETED
Registry status
NA
Development phase
268 participants
Enrollment target

Study Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

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 etafilcon A with novel molding process
  • DEVICE etafilcon A with current molding process

Trial Details

FieldValue
Enrollment Target 268 participants
Start Date 2018-09-24
Est. Completion 2019-04-01
Phase NA
Johnson & Johnson Vision Care

142 total trials

What the finished NCT03701516 record still lists

NCT03701516 is an interventional study that assigns participants to a tested intervention. The registered 268 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 (81% lower).

The record links to 0 conditions, and to 2 interventions - of which etafilcon A with novel molding process is the first listed.

NCT03701516 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03701516 about?

NCT03701516 is a clinical study titled "Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2". This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the ...

What is the current status of trial NCT03701516?

This trial is currently completed. It is a NA study. The enrollment target is 268 participants. The study started on 2018-09-24. Estimated completion is 2019-04-01.

What interventions are being tested in trial NCT03701516?

The interventions under investigation include: etafilcon A with novel molding process (DEVICE), etafilcon A with current molding process (DEVICE).

Who is sponsoring clinical trial NCT03701516?

This trial is sponsored by Johnson & Johnson Vision Care, which has 142 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03701516's enrollment target sits among peer trials

268 392nd of 2000 higher than 1,606 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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Source: ClinicalTrials.gov NCT03701516, the US trial registry maintained by the National Library of Medicine. NCT03701516 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.