Safety and Efficacy of a Contact Lens for Daily Disposable Use

A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Test, daily disposable contact lens; Device: SofLens daily disposable contact lens

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
• Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
• Subjects must be free of any anterior segment disorders.
• Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Exclusion Criteria:

• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who are allergic to any component in the study care products.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test lens; Test contact lens will be worn on a daily disposable wear basis.	Device: Test, daily disposable contact lens; Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Active Comparator: SofLens lens; The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.	Device: SofLens daily disposable contact lens; Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings > Grade 2	Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses	4 visits over 3 months
High Contrast, Distance logMAR Visual Acuity (VA)	Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint	4 visits over 3 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Beverly Barna, CCRA, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 690 (National Heart, Lung, and Blood Institute)

Drug and device information, study documents

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