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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2010-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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).

Group Type OTHER

galy A Plus

Intervention Type DEVICE

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Intervention Type DEVICE

senofilcon A, BC:8.4 or 8.8

galy A

Intervention Type DEVICE

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).

Group Type OTHER

galy A Plus

Intervention Type DEVICE

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Intervention Type DEVICE

senofilcon A, BC:8.4 or 8.8

galy A

Intervention Type DEVICE

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).

Group Type OTHER

galy A Plus

Intervention Type DEVICE

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Intervention Type DEVICE

senofilcon A, BC:8.4 or 8.8

galy A

Intervention Type DEVICE

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).

Group Type OTHER

galy A Plus

Intervention Type DEVICE

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Intervention Type DEVICE

senofilcon A, BC:8.4 or 8.8

galy A

Intervention Type DEVICE

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).

Group Type OTHER

galy A Plus

Intervention Type DEVICE

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Intervention Type DEVICE

senofilcon A, BC:8.4 or 8.8

galy A

Intervention Type DEVICE

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).

Group Type OTHER

galy A Plus

Intervention Type DEVICE

galyfilcon A Plus, BC: 8.3 or 8.7

seno A

Intervention Type DEVICE

senofilcon A, BC:8.4 or 8.8

galy A

Intervention Type DEVICE

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

Intervention Type DEVICE

seno A

senofilcon A, BC:8.4 or 8.8

Intervention Type DEVICE

galy A

galyfilcon A , BC: 8.3 or 8.7

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Farnham, Surrey, United Kingdom

Site Status

Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CR-201011

Identifier Type: -

Identifier Source: org_study_id

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