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

Not Applicable

Completed

Conditions: Myopia
Contact Lenses

Interventions: Device: Bausch & Lomb new daily disposable
Device: Johnson & Johnson Acuvue Moist

Registration Number: NCT01192126

Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bausch & Lomb new daily disposable	Bausch & Lomb new daily disposable	New daily disposable contact lenses
Johnson & Johnson Acuvue Moist	Johnson & Johnson Acuvue Moist	Contact lenses

Primary Outcome Measures

Name	Time	Method
Visual Acuity	Dispensing Visit and 1 week follow-up	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.
Slit Lamp Examination > Grade 2	All study visits from screening through 2 week follow-up	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.

Secondary Outcome Measures