Study of A New Contact Lens Cleaning and Disinfecting Solution

Bausch + Lomb

Status: Completed

Conditions: Vision Disorders

Treatments: Device: Clear Care Solution; Device: Investigational Cleaning & Disinfecting Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318577

682

Details and patient eligibility

About

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.

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

444 participants in 2 patient groups

Investigational Solution

Experimental group

Description:

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

Treatment:

Device: Investigational Cleaning & Disinfecting Solution

Clear Care Solution

Active Comparator group

Description:

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

Treatment:

Device: Clear Care Solution