Study of A New Contact Lens Cleaning and Disinfecting Solution

NCT ID: NCT01318577

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 444 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-06-30

Brief Summary

The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.

Conditions

Vision Disorders

Study Design

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

Study Groups

Investigational Solution

Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.

Group Type: EXPERIMENTAL

Investigational Cleaning & Disinfecting Solution

Intervention Type: DEVICE

Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Clear Care Solution

Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses

Group Type: ACTIVE_COMPARATOR

Clear Care Solution

Intervention Type: DEVICE

Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Interventions

Investigational Cleaning & Disinfecting Solution

Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Intervention Type: DEVICE

Clear Care Solution

Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must be habitual wearers of one of the protocol specified lenses.
• Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
• 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 agree to wear their lenses on a daily wear basis for approximately three months.

Exclusion Criteria

• Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
• Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
• Subjects 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 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 who are allergic to any component in the study care products.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly Barna

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

682

Identifier Type: -

Identifier Source: org_study_id