Study of A New Contact Lens Cleaning and Disinfecting Solution

Vision Disorders Clinical Trial

Official title:

Study of A New Contact Lens Cleaning and Disinfecting Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318577
• Other study ID #: 682
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vision Disorders

Intervention

Device:
• Investigational Cleaning & Disinfecting Solution
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
• Clear Care Solution
Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Locations

Country	Name	City	State
United States	Bausch & Lomb Incorporated	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With > Grade 2 Slit Lamp Findings	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.	3 months