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

NCT ID: NCT01192126

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2010-10-31

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.

Conditions

Myopia; Contact Lenses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Bausch & Lomb new daily disposable

New daily disposable contact lenses

Group Type: EXPERIMENTAL

Bausch & Lomb new daily disposable

Intervention Type: DEVICE

Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Johnson & Johnson Acuvue Moist

Contact lenses

Group Type: ACTIVE_COMPARATOR

Johnson & Johnson Acuvue Moist

Intervention Type: DEVICE

Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Interventions

Bausch & Lomb new daily disposable

Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Intervention Type: DEVICE

Johnson & Johnson Acuvue Moist

Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bev Barna

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb

Rochester, New York, United States

Countries

United States

Other Identifiers

662

Identifier Type: -

Identifier Source: org_study_id