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

Contact Lenses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982046
• Other study ID #: M-09-05
• Status: Completed
• Phase: N/A
• First received: September 18, 2009
• Last updated: November 15, 2016
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lenses

Intervention

Device:
• Opti-Free RepleniSH multi-purpose disinfecting solution
Contact lens solution CE-marked for intended use.
• ReNu MultiPlus multi-purpose solution
Contact lens solution CE-marked for intended use.
• Clear Care cleaning and disinfecting system
Contact lens care system CE-marked for intended use.
• Senofilcon A contact lens (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.
• Lotrafilcon B contact lens (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.
• Comfilcon A contact lens (Biofinity)
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.

Locations

Country	Name	City	State
United Kingdom	Visioncare Research Ltd.	Farnham	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Program No 105358. Hall LA, Garofalo R, Young G. Clinical comparison of three contact lens systems in conjunction with senofilcon A, lotrafilcon B and comfilcon A daily wear lenses. American Academy of Optometry 2010.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks	No
Primary	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.	2 weeks	No
Primary	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.	2 weeks	No
Primary	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.	2 weeks	No
Primary	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.	2 weeks	No
Primary	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.	2 weeks	No