Status:
COMPLETED
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Eligibility Criteria
Inclusion
- Must be at least 18 years of age and no more than 55 years of age.
- Must sign written informed consent.
- Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
- Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
- Must have visual acuity best correctable to 20/25+3 or better for each eye.
- Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
Exclusion
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Any previous eye surgery involving the anterior segment.
- Pre-existing ocular disease that would preclude contact lens fitting.
- Abnormal lacrimal secretions.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial.
- Subject's habitual contact lens type is toric or multifocal.
- Require any concurrent ocular medication.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01244529
Start Date
September 1 2010
End Date
November 1 2010
Last Update
June 19 2018
Active Locations (2)
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1
Farnham, Surrey, United Kingdom, GU9 7EN
2
Birmingham, United Kingdom, B4 7ET