A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens

The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson & Johnson Acuvue Moist contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia; Contact Lenses
• Intervention / Treatment: Device: Bausch & Lomb new daily disposable; Device: Johnson & Johnson Acuvue Moist

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers.
• Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week.
• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must have clear central corneas that are free of any anterior segment disorders.
• Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.

Exclusion Criteria:

• Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months.
• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect 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 an active ocular disease or who are using any ocular medication.
• Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
• Subjects who currently wear monovision, multifocal, or toric contact lenses.
• Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
• Subjects with anisometropia (spherical equivalent) of greater than 1.00 D.
• Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation).
• Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
• Subjects with any "Present" finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
• Subjects who are aphakic.
• Subjects who are amblyopic.
• Subjects who have presbyopia.
• 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: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bausch & Lomb new daily disposable; New daily disposable contact lenses	Device: Bausch & Lomb new daily disposable; Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
Active Comparator: Johnson & Johnson Acuvue Moist; Contact lenses	Device: Johnson & Johnson Acuvue Moist; Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.	Dispensing Visit and 1 week follow-up
Slit Lamp Examination > Grade 2	Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.	All study visits from screening through 2 week follow-up

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Bev Barna, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): August 31, 2010

Study Record Updates

• Last Update Posted (Estimate): January 3, 2014
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 662