Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

NCT ID: NCT00697190

Last Updated: 2015-05-22

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-09-30

Brief Summary

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This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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senofilcon A/galyfilcon A

senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.

Group Type ACTIVE_COMPARATOR

senofilcon A toric

Intervention Type DEVICE

silicone hydrogel contact lens for patients with astigmatism

galyfilcon A toric

Intervention Type DEVICE

silicone hydrogel contact lens for patients with astigmatism

galyfilcon A/senofilcon A

galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.

Group Type ACTIVE_COMPARATOR

senofilcon A toric

Intervention Type DEVICE

silicone hydrogel contact lens for patients with astigmatism

galyfilcon A toric

Intervention Type DEVICE

silicone hydrogel contact lens for patients with astigmatism

Interventions

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senofilcon A toric

silicone hydrogel contact lens for patients with astigmatism

Intervention Type DEVICE

galyfilcon A toric

silicone hydrogel contact lens for patients with astigmatism

Intervention Type DEVICE

Other Intervention Names

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Acuvue Oasys for Astigmatism Acuvue Advance for Astigmatism

Eligibility Criteria

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Inclusion Criteria

* Able to wear study lenses in parameters available.
* At least 18
* understand and sign informed consent
* willing to follow the protocol
* achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
* hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
* oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion Criteria

* Any ocular or systemic disorder which may contraindicate Contact Lens (CL) wear
* any topical ocular medication
* aphakic
* corneal refractive surgery,
* corneal distortion from hard CL wear or keratoconus
* pregnant or lactating
* grade 2 or worse slit lamp signs
* infectious disease
* previous clinical study within 2 weeks
* don't agree to participate
Minimum Eligible Age

18 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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Eurolens Research

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CR-4523

Identifier Type: -

Identifier Source: org_study_id

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