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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Johnson and Johnson 1-Day Acuvue Moist contact lenses; Device: Novel Bausch & Lomb daily disposable contact lenses; Device: Bausch & Lomb SofLens daily disposable contact lenses.

• Registration Number: NCT00784641
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-31
• Study First Submitted QC: 2008-10-31
• Study Start: 2008-11
• Study First Posted: 2008-11-04
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Results First Posted: 2020-10-06
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 567

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acuvue	Johnson and Johnson 1-Day Acuvue Moist contact lenses	Johnson and Johnson 1-Day Acuvue Moist contact lenses
Novel Bausch & Lomb Contact Lens	Novel Bausch & Lomb daily disposable contact lenses	Novel Bausch \& Lomb daily disposable contact lenses
SofLens	Bausch & Lomb SofLens daily disposable contact lenses.	Bausch \& Lomb SofLens daily disposable contact lenses

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey	At dispensing	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.

Trial Locations

Locations (1)

Dr. James Ferrari; 🇺🇸 Rochester, New York, United States