Vistakon Investigational Lens Worn as a Single Use Daily Wear

NCT ID: NCT01031004

Last Updated: 2018-06-19

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-01

Study Completion Date

2009-12-01

Brief Summary

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This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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narafilcon B

contact lens

Group Type EXPERIMENTAL

narafilcon B

Intervention Type DEVICE

contact lens

etafilcon A

contact lens

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

contact lens

Interventions

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narafilcon B

contact lens

Intervention Type DEVICE

etafilcon A

contact lens

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
* must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
* distance spherical contact lens prescription must be within the range available for the study

Exclusion Criteria

* systemic diseases which may interfere with contact lens wear
* ocular infection or clinically significant ocular disease
* any previous intraocular surgery
* grade 2 or greater slit lamp findings
* currently pregnant or lactating
* more than 1.00D of refractive astigmatism in either eye
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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Salt Lake City, Utah, United States

Site Status

Virginia Beach, Virginia, United States

Site Status

Laramie, Wyoming, United States

Site Status

Countries

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United States

Other Identifiers

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CR-1655

Identifier Type: -

Identifier Source: org_study_id

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