A Study to Evaluate a Modified Contact Lens

NCT ID: NCT01391364

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 438 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-07-31

Brief Summary

This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SofLens in investigational solution

Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.

Group Type: EXPERIMENTAL

SofLens in investigational solution

Intervention Type: DEVICE

SofLens in investigational solution, worn on a daily disposable basis for 7 days.

SofLens in currently marketed solution

SofLens daily disposable contact lens packaged in currently marketed storage solution.

Group Type: ACTIVE_COMPARATOR

SofLens in currently marketed solution

Intervention Type: DEVICE

SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.

Interventions

SofLens in investigational solution

SofLens in investigational solution, worn on a daily disposable basis for 7 days.

Intervention Type: DEVICE

SofLens in currently marketed solution

SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must be free of any anterior segment disorders.
• Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
• Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
• Subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses.
• Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study.
• Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment.
• Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog).
• Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience.
• Subjects must have access to an internet connection and be able to send and receive email.

Exclusion Criteria

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• 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 an active ocular disease or who are using any ocular medication.
• Subjects with any grade 2 or greater finding during the slit lamp examination
• Subjects with any "Present" finding during the slit lamp examination 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 allergic to any component in the study care products.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bausch & Lomb, Inc.

Rochester, New York, United States

Countries

United States

Other Identifiers

691

Identifier Type: -

Identifier Source: org_study_id