Clinical trial NCT03681808: Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism
Official title: A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2018-09-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
timeFrame: Evaluated at the 1 week follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Bausch Site 117
state: California
city: San Diego
country: United States
facility: Bausch Site 107
state: California
city: San Francisco
country: United States
facility: Bausch Site 101
state: California
city: San Jose
country: United States
facility: Bausch Site 108
state: California
city: Sunnyvale
country: United States
facility: Bausch Site 104
state: California
city: Jacksonville
country: United States
facility: Bausch Site 102
state: Florida
city: Bloomington
country: United States
facility: Bausch Site 116
state: Illinois
city: Brighton
country: United States
facility: Bausch Site 110
state: New York
city: New York
country: United States
facility: Bausch Site 118
state: New York
city: New York
country: United States
facility: Bausch Site 111
state: New York
city: Raleigh
country: United States
facility: Bausch Site 114
state: North Carolina
city: Houston
country: United States
facility: Bausch Site 105
state: Texas
city: Issaquah
country: United States
facility: Bausch Site 115
state: Washington
Study officials:
affiliation: Bausch Health Companies
name: Lindsey Mathew
role: STUDY_DIRECTOR
References: