Completed
NA
INTERVENTIONAL
NCT00982046
A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.
Detailed Description
This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.
Interventions
Name:
Opti-Free RepleniSH multi-purpose disinfecting solution
Type:
DEVICE
Description:
Contact lens solution CE-marked for intended use.
Name:
ReNu MultiPlus multi-purpose solution
Type:
DEVICE
Description:
Contact lens solution CE-marked for intended use.
Name:
Clear Care cleaning and disinfecting system
Type:
DEVICE
Description:
Contact lens care system CE-marked for intended use.
Name:
Senofilcon A contact lens (ACUVUE OASYS)
Type:
DEVICE
Description:
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Name:
Lotrafilcon B contact lens (AIR OPTIX AQUA)
Type:
DEVICE
Description:
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Name:
Comfilcon A contact lens (Biofinity)
Type:
DEVICE
Description:
Silicone hydrogel contact lens worn for two weeks on a daily wear basis and cleaned nightly with one of three contact lens care solutions. The order of solutions was randomized, and a fresh pair of lenses was dispensed with each solution.
Primary Outcomes
Measure:
Modulus
TimeFrame:
2 weeks
Description:
Modulus is a measure of the stiffness of a contact lens material. Modulus is determined from the slope of the stress-strain curve created during tensile tests conducted on a sample of the material. Modulus is measured in mega Pascals (MPa). A higher modulus indicates a stiffer contact lens.
Measure:
Bulbar hyperemia
TimeFrame:
2 weeks
Description:
Bulbar hyperemia is the injection (or redness) of the blood vessels in the tissues overlaying the white of the eye. Bulbar hyperemia is measured on a 0-4 scale, with 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Half-grades are allowed.
Measure:
Corneal staining type
TimeFrame:
2 weeks
Description:
An ophthalmic dye is used to highlight dead or degenerated corneal epithelial cells. The type of staining is measured over the five sectors of the cornea on a 0-4 scale, where 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced macropunctate, and 4=patch (1mm). The five sectors are averaged to give a single score.
Measure:
Upper palpebral roughness
TimeFrame:
2 weeks
Description:
The roughness of the inner lining of the upper eyelid is measured on a 0-4 scale, where 0=uniform appearance, 1=trace, 2=mild, 3=moderate, and 4=severe. Half grades are allowed.
Measure:
High contrast visual acuity
TimeFrame:
2 weeks
Description:
High contrast visual acuity is a measure of the clearness of vision with full room illumination. Visual acuity is measured with a computer-generated, high contrast logMAR (logarithm minimum angle of resolution) chart.
Measure:
End of day comfort
TimeFrame:
2 weeks
Description:
As assessed by the subject as a measure of the comfort of the contact lenses at the end of an average day. End of day comfort is recorded on an 11-point scale where 0=poor and 10=excellent.
Trial Information
NCT ID
NCT00982046
Status
Completed
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Alcon Research
Last Updated
December 15, 2025