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COMPLETED NA

Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses

NCT04555031 · View on ClinicalTrials.gov ↗

Study Summary

Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.

Interventions

  • DEVICE kalifilcon A lenses
  • DEVICE Dalies Total 1
  • DEVICE Precision 1
  • DEVICE Biotrue ONEday

Study Locations (1)

New York

  • Bausch and Lomb Site 01 — Rochester

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-09-09
Est. Completion 2020-09-16
Phase NA

Sponsor

Bausch & Lomb Incorporated

78 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04555031

The ClinicalTrials.gov registry entry for NCT04555031 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Habitual Soft Contact Lens Use appearing as the primary indexed condition, and to 4 interventions — of which kalifilcon A lenses is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04555031 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04555031 about?

NCT04555031 is a clinical study titled "Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses". Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be ob...

What is the current status of trial NCT04555031?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2020-09-09. Estimated completion is 2020-09-16.

What conditions does trial NCT04555031 study?

This clinical trial studies the following conditions: Habitual Soft Contact Lens Use. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04555031?

The interventions under investigation include: kalifilcon A lenses (DEVICE), Dalies Total 1 (DEVICE), Precision 1 (DEVICE), Biotrue ONEday (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04555031?

This trial is sponsored by Bausch & Lomb Incorporated, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04555031 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial