A Study to Evaluate a New Silicone Hydrogel Contact Lens

NCT ID: NCT01309893

Last Updated: 2014-11-24

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-02-28

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 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

Blinding Strategy

SINGLE

Participants

Study Groups

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Investigational Lens

Bausch \& Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week.

Group Type EXPERIMENTAL

Investigational Lens

Intervention Type DEVICE

Lenses worn on a daily wear basis for one week

Air Optix Aqua lens

Intervention Type DEVICE

Lenses worn on a daily wear basis for one week

Air Optix Aqua Lens

Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week.

Group Type ACTIVE_COMPARATOR

Investigational Lens

Intervention Type DEVICE

Lenses worn on a daily wear basis for one week

Air Optix Aqua lens

Intervention Type DEVICE

Lenses worn on a daily wear basis for one week

Interventions

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Investigational Lens

Lenses worn on a daily wear basis for one week

Intervention Type DEVICE

Air Optix Aqua lens

Lenses worn on a daily wear basis for one week

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria

* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.
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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Robert Steffen, OD, MS

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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687E

Identifier Type: -

Identifier Source: org_study_id