Study of A New Contact Lens Cleaning and Disinfecting Solution

Not Applicable

Completed

• Conditions: Vision Disorders
• Interventions: Device: Investigational Cleaning & Disinfecting Solution; Device: Clear Care Solution

• Registration Number: NCT01318577
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-16
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Results First Submitted: 2020-08-21
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-05
• Results First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Solution	Investigational Cleaning & Disinfecting Solution	Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.
Clear Care Solution	Clear Care Solution	Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With > Grade 2 Slit Lamp Findings	3 months	Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States