Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Test; Device: Control

• Registration Number: NCT03681808
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-24
• Study Start: 2018-10-10
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Results First Submitted: 2020-11-23
• Results First Submitted QC: 2020-11-23
• Results First Posted: 2020-12-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-06
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Test	Soft Contact Lens
Control	Control	Contact lens

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better	Evaluated at the 1 week follow up visit	The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes

Trial Locations

Locations (13)

Bausch Site 117; 🇺🇸 Irvine, California, United States

Bausch Site 102; 🇺🇸 Jacksonville, Florida, United States

Bausch Site 108; 🇺🇸 San Jose, California, United States

Bausch Site 104; 🇺🇸 Sunnyvale, California, United States

Bausch Site 116; 🇺🇸 Bloomington, Illinois, United States

Bausch Site 111; 🇺🇸 New York, New York, United States

Bausch Site 110; 🇺🇸 Brighton, New York, United States

Bausch Site 118; 🇺🇸 New York, New York, United States

Bausch Site 114; 🇺🇸 Raleigh, North Carolina, United States

Bausch Site 115; 🇺🇸 Issaquah, Washington, United States

Bausch Site 107; 🇺🇸 San Diego, California, United States

Bausch Site 101; 🇺🇸 San Francisco, California, United States

Bausch Site 105; 🇺🇸 Houston, Texas, United States