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A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens

NCT ID: NCT01130974

Last Updated: 2013-12-10

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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The objective of this study is to evaluate the safety and efficacy of the Bausch \& Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bausch & Lomb contact lens

Bausch \& Lomb daily disposable cosmetic tint contact lens

Group Type EXPERIMENTAL

Bausch & Lomb contact lens

Intervention Type DEVICE

Bausch \& Lomb daily disposable cosmetic tint contact lens

Marketed daily disposable contact lens

Marketed daily disposable cosmetic tint contact lens

Group Type ACTIVE_COMPARATOR

Marketed daily disposable contact lens

Intervention Type DEVICE

Marketed daily disposable cosmetic tint contact lens

Interventions

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Bausch & Lomb contact lens

Bausch \& Lomb daily disposable cosmetic tint contact lens

Intervention Type DEVICE

Marketed daily disposable contact lens

Marketed daily disposable cosmetic tint contact lens

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 correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Subjects must be of Asian descent.
* Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.

Exclusion Criteria

* Subjects who have 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.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
* Subjects who currently wear monovision, multifocal, or toric contact lenses.
* Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Bev Barna

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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639

Identifier Type: -

Identifier Source: org_study_id