Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Test; Device: 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 Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Bausch Site 117
    • San Diego, California, United States, 92123
      • Bausch Site 107
    • San Francisco, California, United States, 94112
      • Bausch Site 101
    • San Jose, California, United States, 95132
      • Bausch Site 108
    • Sunnyvale, California, United States, 94087
      • Bausch Site 104
  • Florida
    • Jacksonville, Florida, United States, 32250
      • Bausch Site 102
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Bausch Site 116
  • New York
    • Brighton, New York, United States, 14618
      • Bausch Site 110
    • New York, New York, United States, 10022
      • Bausch Site 118
    • New York, New York, United States, 10036
      • Bausch Site 111
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Bausch Site 114
  • Texas
    • Houston, Texas, United States, 77204
      • Bausch Site 105
  • Washington
    • Issaquah, Washington, United States, 98027
      • Bausch Site 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test; Soft Contact Lens	Device: Test; Soft Contact Lens
Active Comparator: Control; Contact lens	Device: Control; Contact Lens

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No