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Clinical Validation of the New Print on Focus DAILIES Toric

NCT ID: NCT01097863

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

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to validate the improvements to the inversion indicator.

Detailed Description

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This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

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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nelfilcon A, modified inversion indicator

Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

Group Type EXPERIMENTAL

nelfilcon A contact lens, modified inversion indicator

Intervention Type DEVICE

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator

nelfilcon A, no inversion indicator

Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week

Group Type EXPERIMENTAL

nelfilcon A contact lens, no inversion indicator

Intervention Type DEVICE

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator

nelfilcon A, inversion indicator

Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.

Group Type ACTIVE_COMPARATOR

nelfilcon A contact lens, inversion indicator

Intervention Type DEVICE

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator

Interventions

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nelfilcon A contact lens, modified inversion indicator

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator

Intervention Type DEVICE

nelfilcon A contact lens, no inversion indicator

Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator

Intervention Type DEVICE

nelfilcon A contact lens, inversion indicator

Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator

Intervention Type DEVICE

Other Intervention Names

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Focus DAILIES Toric

Eligibility Criteria

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Inclusion Criteria

* Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent.
* Willing and able to wear study lenses in both eyes in the available parameters.
* Light-eyed subjects.
* Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing.
* Optimal or acceptable fit in each eye at time of dispensing.
* Willing to wear the study lenses at least 8 hours a day, 5 days a week.

Exclusion Criteria

* Eye injury or surgery within twelve weeks prior to enrollment for this trial.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* RGP contact lens wearer.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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P-346-C-010

Identifier Type: -

Identifier Source: org_study_id