Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
NCT ID: NCT03681808
Last Updated: 2021-01-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
242 participants
INTERVENTIONAL
2018-10-10
2019-12-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
NCT04555031
Orientation Characteristics of Daily Disposable Toric Contact Lenses
NCT06069609
1-Week Dispensing Evaluation of Kalifilcon A Toric Contact Lenses Compared to Ultra for Astigmatism
NCT05320042
Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses
NCT05129488
Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line
NCT04794270
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test
Soft Contact Lens
Test
Soft Contact Lens
Control
Contact lens
Control
Contact Lens
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Control
Contact Lens
Test
Soft Contact Lens
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lindsey Mathew
Role: STUDY_DIRECTOR
Bausch Health Companies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bausch Site 117
Irvine, California, United States
Bausch Site 107
San Diego, California, United States
Bausch Site 101
San Francisco, California, United States
Bausch Site 108
San Jose, California, United States
Bausch Site 104
Sunnyvale, California, United States
Bausch Site 102
Jacksonville, Florida, United States
Bausch Site 116
Bloomington, Illinois, United States
Bausch Site 110
Brighton, New York, United States
Bausch Site 118
New York, New York, United States
Bausch Site 111
New York, New York, United States
Bausch Site 114
Raleigh, North Carolina, United States
Bausch Site 105
Houston, Texas, United States
Bausch Site 115
Issaquah, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
885
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.