Clinical Performance Comparison of Several Different Contact Lenses

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT00912028
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-01
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-03
• Primary Completion: 2010-02-01
• Study Completion: 2010-02-01
• Results First Submitted: 2014-03-27
• Results First Submitted QC: 2014-03-27
• Results First Posted: 2014-04-28
• Status Verified: 2017-08
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Subjects must:

• be existing soft contact lens wearers of the study control lenses
• require a distance visual correction in both eyes
• have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
• have astigmatism less than or equal to 1.00D in both eyes
• be able to wear lenses available for this study
• be corrected to a visual acuity of 6/9 (20/30) or better in each eye
• have normal eyes with no evidence of abnormality or disease

Exclusion Criteria

Subject are excluded for the following reasons:

• monovision corrected
• worn lenses extended wear in the last 3 months.
• require concurrent ocular medication
• grade 3 or 4 abnormalities
• grade 3 corneal staining in more than two regions
• anterior ocular surgery
• any other ocular surgery or injury within 8 weeks prior to study enrollment
• abnormal lachrymal secretions
• pre-existing ocular irritation that would preclude contact lens fitting
• corneal irregularities
• Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
• any systemic illness which would preclude contact lens wear
• diabetes
• infectious or immunosuppressive disease
• pregnancy or lactating, or planning pregnancy at time or enrollment
• participating in a concurrent clinical study or within last 60 days
• allergy to the standardized study care solution

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Limbal Hyperemia (Redness)	4 weeks	Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Bulbar Hyperemia (Redness)	4 weeks	Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Corneal Staining	4 weeks	Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.