Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Astigmatism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681808
• Other study ID #: 885
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: December 16, 2019

Study information

• Verified date: January 2021
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Control
Contact Lens
• Test
Soft Contact Lens

Locations

Country	Name	City	State
United States	Bausch Site 116	Bloomington	Illinois
United States	Bausch Site 110	Brighton	New York
United States	Bausch Site 105	Houston	Texas
United States	Bausch Site 117	Irvine	California
United States	Bausch Site 115	Issaquah	Washington
United States	Bausch Site 102	Jacksonville	Florida
United States	Bausch Site 111	New York	New York
United States	Bausch Site 118	New York	New York
United States	Bausch Site 114	Raleigh	North Carolina
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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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