A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784641
• Other study ID #: 496
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: January 2009

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.

• Subjects must have clear central corneas and be free of any anterior segment disorders.

• Subjects must be myopic and require lens correction in both eyes.

Exclusion Criteria:

• Subjects with any systemic disease affecting ocular health.

• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Subjects wearing monovision, multifocal or toric contact lenses.

• Subjects with grade 2 or greater slit lamp findings.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Novel Bausch & Lomb daily disposable contact lenses
Lenses to be worn and replaced daily for 2 weeks.
• Bausch & Lomb SofLens daily disposable contact lenses.
Lenses to be worn and replaced daily for 2 weeks.
• Johnson and Johnson 1-Day Acuvue Moist contact lenses
Lenses to be worn and replaced daily for 2 weeks.

Locations

Country	Name	City	State
United States	Dr. James Ferrari	Rochester	New York

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	Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey	The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.	At dispensing