A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
- Conditions
- Contact Lenses
- Registration Number
- NCT00982046
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Signed informed consent.
- Adapted contact lens wearer for at least one month.
- Spherical prescription range between +6.00 to -8.00 diopters.
- Astigmatism of less than or equal to 1.00 diopter in at least one eye.
- Normal eyes with no evidence of abnormality or disease.
- Other protocol-defined inclusion criteria may apply.
- Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
- Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
- Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
- Eye injury or surgery within 8 weeks prior to study.
- Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method End of day comfort 2 weeks 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.
Bulbar hyperemia 2 weeks 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.
Corneal staining type 2 weeks 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.
Upper palpebral roughness 2 weeks 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.
High contrast visual acuity 2 weeks 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.
Modulus 2 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Visioncare Research Ltd.
🇬🇧Farnham, Surrey, United Kingdom
Visioncare Research Ltd.🇬🇧Farnham, Surrey, United Kingdom