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
NCT ID: NCT01244529
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2010-09-01
2010-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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galy A Plus/ galy A / seno A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
galy A Plus / seno A / galy A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
galy A / galy A Plus / seno A
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
galy A / seno A / galy A Plus
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
seno A / galy A / glay A Plus
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
seno A / galy A Plus / galy A
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
Interventions
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galy A Plus
galyfilcon A Plus, BC: 8.3 or 8.7
seno A
senofilcon A, BC:8.4 or 8.8
galy A
galyfilcon A , BC: 8.3 or 8.7
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Farnham, Surrey, United Kingdom
Birmingham, , United Kingdom
Countries
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Other Identifiers
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CR-201011
Identifier Type: -
Identifier Source: org_study_id
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