N/A
N=242
Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT03681808 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better — 105; 92 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control (Device); Test (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better |
105; 92 | — |
Summary
Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).
Eligibility Criteria
Inclusion Criteria
- Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
- Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
- Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
- Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria
- Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
- Subject has systemic disease affecting ocular health.
- Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
- Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
- Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
Data sourced from ClinicalTrials.gov (NCT03681808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.