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NCT03388138 · ClinicalTrials.gov registry record · Phase 2

Clinical Evaluation of Etafilcon A With Ketotifen

A Phase 2 study, sponsored by Johnson & Johnson Vision Care.

Completed
Registry status
Phase 2
Development phase
143
Enrollment target

NCT03388138: Completed Phase 2 study, sponsored by Johnson & Johnson Vision Care.

NCT03388138 is a Phase 2 study that has completed, run by Johnson & Johnson Vision Care. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03388138, a Phase 2 study, has completed, sponsored by Johnson & Johnson Vision Care.

COMPLETED
Registry status
Phase 2
Development phase
143 participants
Enrollment target

Study Summary

This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.

Primary Outcome

Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

Interventions

  • COMBINATION_PRODUCT etafilcon A with ketotifen
  • DEVICE 1-Day ACUVUE

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2017-12-06
Est. Completion 2018-02-09
Phase Phase 2
Johnson & Johnson Vision Care

142 total trials

What the finished NCT03388138 record still lists

NCT03388138 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

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

NCT03388138 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03388138 about?

NCT03388138 is a clinical study titled "Clinical Evaluation of Etafilcon A With Ketotifen". This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.

What is the current status of trial NCT03388138?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2017-12-06. Estimated completion is 2018-02-09.

What interventions are being tested in trial NCT03388138?

The interventions under investigation include: etafilcon A with ketotifen (COMBINATION_PRODUCT), 1-Day ACUVUE (DEVICE).

Who is sponsoring clinical trial NCT03388138?

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 NCT03388138's enrollment target sits among peer trials

143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03388138, the US trial registry maintained by the National Library of Medicine. NCT03388138 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.