An interventional study of Opti-Free RepleniSH multi-purpose disinfecting solution and ReNu MultiPlus multi-purpose solution in Contact Lenses, sponsored by Alcon Research. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-16.
Sponsored by Alcon Research · Not applicable, Interventional, and Supportive care
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.
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.
Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acuvue Oasys contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Device: Opti-Free RepleniSH multi-purpose disinfecting solution · Device: ReNu MultiPlus multi-purpose solution · Device: Clear Care cleaning and disinfecting system · Device: Senofilcon A contact lens (ACUVUE OASYS)
Air Optix Aqua contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Device: Opti-Free RepleniSH multi-purpose disinfecting solution · Device: ReNu MultiPlus multi-purpose solution · Device: Clear Care cleaning and disinfecting system · Device: Lotrafilcon B contact lens (AIR OPTIX AQUA)
Biofinity contact lenses worn on a daily wear basis and cleaned nightly with one of three contact lens care solutions. Each solution was used for 2 weeks, and the order in which the solutions were used was randomized. A fresh pair of lenses was dispensed with each solution. Total duration of contact lens wear was six weeks.
Device: Opti-Free RepleniSH multi-purpose disinfecting solution · Device: ReNu MultiPlus multi-purpose solution · Device: Clear Care cleaning and disinfecting system · Device: Comfilcon A contact lens (Biofinity)
Contact lens solution CE-marked for intended use.
Also known as: Opti-Free® RepleniSH®
Contact lens solution CE-marked for intended use.
Also known as: ReNu® MultiPlus®
Contact lens care system CE-marked for intended use.
Also known as: Clear Care®
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.
Also known as: ACUVUE® OASYS™
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.
Also known as: AIR OPTIX® AQUA
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.
Also known as: Biofinity®
Modulus
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.
Time frame: 2 weeks
Bulbar hyperemia
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.
Time frame: 2 weeks
Corneal staining type
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.
Time frame: 2 weeks
Upper palpebral roughness
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.
Time frame: 2 weeks
High contrast visual acuity
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.
Time frame: 2 weeks
End of day comfort
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.
Time frame: 2 weeks
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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