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A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses

Not Applicable
Completed
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
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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
NameTimeMethod
End of day comfort2 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 hyperemia2 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 type2 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 roughness2 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 acuity2 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.

Modulus2 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
NameTimeMethod

Trial Locations

Locations (1)

Visioncare Research Ltd.

🇬🇧

Farnham, Surrey, United Kingdom

Visioncare Research Ltd.
🇬🇧Farnham, Surrey, United Kingdom

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