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A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
NCT04158466 · View on ClinicalTrials.gov ↗
Study Summary
This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
Conditions Studied
Interventions
- DEVICE Kalifilcon A Daily Disposable Contact Lenses
- DEVICE Biotrue ONEday Daily Disposable Contact Lenses
Study Locations (16)
California
- Bausch Site 8 — Los Angeles
- Bausch Site 9 — San Francisco
- Bausch Site 10 — Torrance
- Bausch Site 12 — Torrance
Tennessee
- Bausch Site 14 — Brentwood
- Bausch Site 5 — Memphis
- Bausch Site 3 — Nashville
Hawaii
- Bausch Site 16 — Honolulu
- Bausch Site 4 — ‘Aiea
Florida
- Bausch Site 6 — Sarasota
Kansas
- Bausch Site 7 — Pittsburg
Minnesota
- Bausch Site 11 — Bloomington
Missouri
- Bausch Site 1 — St Louis
New York
- Bausch Site 13 — Vestal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2019-05-31 |
| Est. Completion | 2019-11-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04158466
The ClinicalTrials.gov registry entry for NCT04158466 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 252 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 Contact Lens Wear appearing as the primary indexed condition, and to 2 interventions — of which Kalifilcon A Daily Disposable Contact 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: NCT04158466 reports 16 study locations spanning 10 distinct geographic areas — top geographies include California, Tennessee, Hawaii. 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 NCT04158466 about?
NCT04158466 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens". This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
What is the current status of trial NCT04158466?
This trial is currently completed. It is a NA study. The enrollment target is 252 participants. The study started on 2019-05-31. Estimated completion is 2019-11-12.
What conditions does trial NCT04158466 study?
This clinical trial studies the following conditions: Contact Lens Wear. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04158466?
The interventions under investigation include: Kalifilcon A Daily Disposable Contact Lenses (DEVICE), Biotrue ONEday Daily Disposable Contact Lenses (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04158466?
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 NCT04158466 being conducted?
This trial has 16 study locations across California, Florida, Hawaii, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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