đź“Š Evidence-Based Reference
Bausch Lomb Biotrue Oneday for Astigmatism Nesofilcon a Soft Hydrophilic Contact Lens
Bausch & Lomb
Summary: Biotrue ONEday for Astigmatism is a soft hydrophilic contact lens designed for astigmatic patients. It is primarily used to improve vision clarity and comfort. Key evidence highlights user satisfaction and safety in real-world settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K143632 ↗
Decision Date ?
February 13, 2015
Product Code ?
LPL
Device Class ?
Class 2
Evidence ?
419 studies
The Biotrue ONEday for Astigmatism lens by Bausch & Lomb was cleared via the FDA 510(k) pathway on February 13, 2015. It is classified as a Class 2 medical device under product code LPL.
What It Is
The Biotrue ONEday for Astigmatism is a daily disposable contact lens made from nesofilcon A, designed to correct astigmatism by providing clear and comfortable vision. It is intended for use by individuals with astigmatism who require vision correction.
FDA-Cleared Indications
- For daily wear as a soft contact lens to correct refractive ametropia, including astigmatism, in people with healthy eyes.
- For correction of vision in patients with astigmatism who require a toric contact lens.
- For single-use daily disposable wear, with the lens discarded after removal.
Clinical Applications
- Daily vision correction for people with astigmatism.
- Toric contact lens wear during waking hours.
- Use as an alternative to eyeglasses or reusable contact lenses when prescribed and fitted by an eye-care professional.
Evidence Summary
The available literature includes 6 studies, with a mix of randomized controlled trials and other study types. The studies range from 2022 to present, focusing on user satisfaction, safety, and effectiveness of the lens.
Reported Outcomes
Published studies report high levels of satisfaction among astigmatic patients using the Biotrue ONEday lens, with improvements in comfort and vision clarity. The lens has been shown to perform well in real-world settings, with users reporting positive experiences.
Safety Profile
Reported complications include minimal adverse events, with most users experiencing no significant issues. The safety profile of the lens is consistent with other daily disposable lenses, with no major safety concerns highlighted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term data. Further research is needed to explore the long-term safety and effectiveness of the lens, as well as its performance in diverse patient populations.
Practical Considerations
- The lens must be prescribed and fitted by an eye-care professional; the prescription includes sphere, cylinder, axis and other fitting parameters.
- It is intended for daily disposable wear and should not be reused, stored overnight, or worn while sleeping unless the labeling specifically permits it.
- Users should wash and dry their hands before handling the lens and should discard it if it is damaged, contaminated, or causes persistent discomfort or vision changes.
- Contact lenses are generally not compatible with swimming or exposure to nonsterile water because of infection risk.
- Do not use during active eye infection, significant eye inflammation, or when the eye-care professional advises against contact-lens wear. Remove the lens and seek prompt eye care for pain, marked redness, light sensitivity, discharge, or sudden vision loss.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for Biotrue ONEday for Astigmatism?
The lens is indicated for the correction of astigmatism in patients who require vision correction and prefer a daily disposable lens.
What outcomes have been reported in clinical studies?
Studies report high satisfaction rates, improved comfort, and clear vision among users of the Biotrue ONEday lens.
What complications have been reported?
Safety data indicates minimal adverse events, with no major complications reported in the available studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.