In-vivo Wettability Grading and Assessment Study

NCT ID: NCT01010555

Last Updated: 2012-07-10

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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lotrafilcon B

Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Group Type ACTIVE_COMPARATOR

lotrafilcon B

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

balafilcon A

Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Group Type ACTIVE_COMPARATOR

balafilcon A

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

senofilcon A

Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

enfilcon A

Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Group Type ACTIVE_COMPARATOR

enfilcon A

Intervention Type DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

Interventions

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lotrafilcon B

Commercially marketed, silicone hydrogel, spherical contact lens

Intervention Type DEVICE

balafilcon A

Commercially marketed, silicone hydrogel, spherical contact lens

Intervention Type DEVICE

senofilcon A

Commercially marketed, silicone hydrogel, spherical contact lens

Intervention Type DEVICE

enfilcon A

Commercially marketed, silicone hydrogel, spherical contact lens

Intervention Type DEVICE

Other Intervention Names

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Air Optix PureVision Acuvue OASYS Avaira

Eligibility Criteria

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Inclusion Criteria

* is at least 17 years of age
* has read and signed an information consent letter
* is a current daily wear contact lens wearer
* has acceptable fit with the study lenses
* has had an ocular exam in the last two years

Exclusion Criteria

* has any ocular disease
* has undergone corneal refractive surgery or is aphakic
* has any systemic disease affecting ocular health
* is pregnant or lactating
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Waterloo

OTHER

Sponsor Role collaborator

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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P-368-C-104

Identifier Type: -

Identifier Source: org_study_id