Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Completed · Not applicable

Conditions studied: Astigmatism

In brief

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Key facts

Study ID

NCT03681808

Run by

Bausch & Lomb Incorporated

People needed

242

Starts

2018-10-10

Expected to finish

2019-12-16

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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