Product Feasibility of a New Silicone Hydrogel Contact Lens

NCT ID: NCT01309100

Last Updated: 2014-04-29

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

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-01-31

Brief Summary

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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational Lens

Bausch \& Lomb investigational silicone hydrogel lens.

Group Type EXPERIMENTAL

Investigational Lens

Intervention Type DEVICE

Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Acuvue Oasys Lens

Johnson \& Johnson Acuvue Oasys contact lens.

Group Type ACTIVE_COMPARATOR

Acuvue Oasys Lens

Intervention Type DEVICE

Johnson \& Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.

Air Optix Aqua Lens

Ciba Vision Air Optix Aqua contact lens.

Group Type ACTIVE_COMPARATOR

Air Optix Aqua Lens

Intervention Type DEVICE

Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Interventions

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Investigational Lens

Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Intervention Type DEVICE

Acuvue Oasys Lens

Johnson \& Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.

Intervention Type DEVICE

Air Optix Aqua Lens

Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require lens correction

Exclusion Criteria

* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tara Vaz, OD

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb Incorporated

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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672E

Identifier Type: -

Identifier Source: org_study_id

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